ESENTA

Additional Manufacturer Narrative

E1: NAME OF AFFILIATION: (B)(6). THE DEVICE HAS MALFUNCTIONED AND WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF IT WERE TO RECUR. BASED ON THE CIRCUMSTANCES OF THE REPORTED COMPLAINT, THE CASE HAS BEEN SUBMITTED AS A REPORTABLE MALFUNCTION AND THERE WAS MINOR HARM EXPERIENCED, AND IT HAS BEEN REPORTED UNDER IMDRF HEALTH IMPACT CODE AND CLINICAL CODE. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. THIS COMPLAINT HAS BEEN EVALUATED. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 1049092 THIRD PARTY MANUFACTURING SITE: 3010605379.

Description of Event or Problem

THE NURSE REPORTED THAT A FIRE OCCURRED AFTER USE OF THE COMPANY'S KNOWN REMOVER SPRAY WHICH CAUGHT A PATIENT'S BLOUSE ON FIRE. IT WAS MENTIONED THAT THE PATIENT WAS SEEN IN THEIR OUTPATIENT CARDIAC CLINIC TO HAVE A REACT EXTERNAL CARDIAC MONITORING DEVICE REMOVED. THE TECHNICIAN IN THE CLINIC USED THE COMPANY'S KNOWN REMOVER SPRAY TO ASSIST WITH REMOVING THE ADHESIVE PADS AND THEN WIPED THE AREA WITH AN ALCOHOL PAD. THE TECHNICIAN TURNED AROUND FOR A MOMENT AND WHEN SHE TURNED BACK AROUND, THE PATIENT'S BLOUSE WAS ON FIRE. IT WAS STATED THAT THE FIRE WAS SMALL AND ABLE TO BE PATTED OUT WITH THE TECHNICIAN'S HANDS. THE PATIENT WORE A SYNTHETIC BLOUSE AND LOTS OF BABY POWDER ON HER BODY. THEY SENT THE PATIENT TO THE EMERGENCY ROOM WHERE SHE WAS TREATED FOR FIRST DEGREE BURNS TO HER CHEST AND THE MEDICAL CENTER HAD PHOTOS OF SMALL AREAS WITH BLISTERING. THE EMERGENCY ROOM CLEANSED THE BURNS AND TREATED THEM WITH BACITRACIN (POLYPEPTIDE ANTIBIOTIC). NO OXYGEN WAS IN USE AT TIME OF THE INCIDENT. FURTHERMORE, IT WAS MENTIONED THAT THE PATIENT DID NOT HAVE ANY DEFIBRILLATOR OR EXTERNAL DEVICES. AGE OF THE PATIENT WAS UNKNOWN. NO PHOTO AVAILABLE IS AVAILABLE AT THIS TIME.

Description of Event or Problem

TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS H11: INVESTIGATION SUMMARY: THE ESENTA SPRAY PRODUCTS, BY NECESSITY TO MEET THE PERFORMANCE AND FUNCTIONALITY REQUIREMENTS, DO CONTAIN FLAMMABLE SOLVENTS AND THE PRODUCT WAS CLASSIFIED AS FLAMMABLE. THIS WAS CONVEYED TO THE USER BY THE PRESENCE OF THE FLAMMABLE SYMBOL ON THE CAN AND THE ASSOCIATED WARNINGS IN THE INFORMATION / INSTRUCTION FOR USE (IFU) LEAFLET PROVIDED WITH EACH CAN. THE WARNINGS CLEARLY STATE THAT THE PRODUCT IS EXTREMELY FLAMMABLE AND MUST BE KEPT AWAY FOR HEAT OR ANY POTENTIAL IGNITION SOURCE. BOTH THE ESENTA ADHESIVE REMOVER AND ESENTA BARRIER SPRAY CONTAIN >94% HEXAMETHYLDISILOXANE AS THE PRIMARY SOLVENT (HIGHLY FLAMMABLE LIQUID) AND COULD POTENTIALLY BE IGNITED FROM ANY POTENTIAL IGNITION SOURCE. UNFORTUNATELY, EVALUATION OF THE COMPLAINT CAN WAS UNLIKELY TO IDENTIFY WHAT MAY HAVE CAUSED THE SPRAY TO IGNITE. IN-ORDER TO TRY TO ESTABLISH THE CAUSE, DETAILED INFORMATION WAS LIKELY TO BE REQUIRED CONCERNING THE EXACT USAGE CIRCUMSTANCES, INCLUDING ALL THE SURROUNDING ENVIRONMENT, WHICH MAY HAVE PROVIDED THE IGNITION SOURCE. WITHOUT THE SPECIFIC LOT NUMBER FOR THE COMPLAINT PRODUCT, WE ARE UNABLE TO CONFIRM SPECIFIC DETAILS FOR THE RAW MATERIAL BATCHES USED IN THE COMPLAINT PRODUCT BUT CAN CONFIRM THAT ALL EVERY BATCH OF PRODUCT CONCENTRATE WAS ANALYSED IN ACCORDANCE WITH YOUR PRODUCT SPECIFICATIONS, PRIOR TO USE. NB THE FINISHED PRODUCT CONCENTRATE WAS MANUFACTURED IN THE STEEL 210 LITRE DRUM IT WAS SUPPLIED TO US, THUS PREVENTING CROSS-CONTAMINATION. IF THE CONCENTRATE DOES NOT MEET YOUR SPECIFICATION, IT WILL NOT BE USED. FOLLOWING ARE THE MEASURES TO BE TAKEN: FIREFIGHTING MEASURES: EXTINGUISHING MEDIA: SUITABLE EXTINGUISHING MEDIA: FOAM. DRY POWDER. CARBON DIOXIDE. WATER SPRAY. SAND. UNSUITABLE EXTINGUISHING MEDIA: DO NOT USE A HEAVY WATER STREAM. ACCIDENTAL RELEASE MEASURES: PERSONAL PRECAUTIONS, PROTECTIVE EQUIPMENT AND EMERGENCY PROCEDURES: GENERAL MEASURES: REMOVE IGNITION SOURCES. USE SPECIAL CARE TO AVOID STATIC ELECTRIC CHARGES. NO OPEN FLAMES. NO SMOKING. FOR NON-EMERGENCY PERSONNEL: EMERGENCY PROCEDURES: EVACUATE UNNECESSARY PERSONNEL. FOR EMERGENCY RESPONDERS: PROTECTIVE EQUIPMENT: EQUIP CLEANUP CREW WITH PROPER PROTECTION. EMERGENCY PROCEDURES: VENTILATE AREA. ENVIRONMENTAL PRECAUTIONS PREVENT ENTRY TO SEWERS AND PUBLIC WATERS. NOTIFY AUTHORITIES IF LIQUID ENTERS SEWERS OR PUBLIC WATERS. AVOID RELEASE TO THE ENVIRONMENT. METHODS AND MATERIAL FOR CONTAINMENT AND CLEANING UP: METHODS FOR CLEANING UP: SOAK UP SPILLS WITH INERT SOLIDS, SUCH AS CLAY OR DIATOMACEOUS EARTH AS SOON AS POSSIBLE. COLLECT SPILLAGE. STORE AWAY FROM OTHER MATERIALS. HANDLING AND STORAGE: PRECAUTIONS FOR SAFE HANDLING: ADDITIONAL HAZARDS WHEN PROCESSED: HANDLE EMPTY CONTAINERS WITH CARE BECAUSE RESIDUAL VAPOURS ARE FLAMMABLE. PRECAUTIONS FOR SAFE HANDLING: WASH HANDS AND OTHER EXPOSED AREAS WITH MILD SOAP AND WATER BEFORE EATING, DRINKING OR SMOKING AND WHEN LEAVING WORK. PROVIDE GOOD VENTILATION IN PROCESS AREA TO PREVENT FORMATION OF VAPOUR. NO OPEN FLAMES. NO SMOKING. USE ONLY NON-SPARKING TOOLS. CONDITIONS FOR SAFE STORAGE, INCLUDING ANY INCOMPATIBILITIES: TECHNICAL MEASURES: PROPER GROUNDING PROCEDURES TO AVOID STATIC ELECTRICITY SHOULD BE FOLLOWED. GROUND/BOND CONTAINER AND RECEIVING EQUIPMENT. USE EXPLOSION-PROOF ELECTRICAL/VENTILATING/LIGHTING EQUIPMENT. STORAGE CONDITIONS: KEEP ONLY IN THE ORIGINAL CONTAINER IN A COOL, WELL-VENTILATED PLACE AWAY FROM: KEEP IN FIREPROOF PLACE. KEEP CONTAINER TIGHTLY CLOSED. INCOMPATIBLE PRODUCTS: STRONG BASES. STRONG ACIDS. INCOMPATIBLE MATERIALS: SOURCES OF IGNITION. DIRECT SUNLIGHT. HEAT SOURCES. STABILITY AND REACTIVITY: REACTIVITY; NO ADDITIONAL INFORMATION AVAILABLE. CHEMICAL STABILITY: HIGHLY FLAMMABLE LIQUID AND VAPOUR. MAY FORM FLAMMABLE/EXPLOSIVE VAPOUR-AIR MIXTURE. POSSIBILITY OF HAZARDOUS REACTIONS: NOT ESTABLISHED. CONDITIONS TO AVOID: DIRECT SUNLIGHT. EXTREMELY HIGH OR LOW TEMPERATURES. OPEN FLAME. INCOMPATIBLE MATERIALS: STRONG ACIDS. STRONG BASES. HAZARDOUS DECOMPOSITION PRODUCTS: FUME. CARBON MONOXIDE. CARBON DIOXIDE. MAY RELEASE FLAMMABLE GASES. DISPOSAL CONSIDERATIONS: WASTE TREATMENT METHODS: PRODUCT/PACKAGING DISPOSAL RECOMMENDATIONS: DISPOSE IN A SAFE MANNER IN ACCORDANCE WITH LOCAL/NATIONAL REGULATIONS. DISPOSE OF CONTENTS/CONTAINER. ADDITIONAL INFORMATION: HANDLE EMPTY CONTAINERS WITH CARE BECAUSE RESIDUAL VAPOURS ARE FLAMMABLE. ECOLOGICAL WASTE INFORMATION: AVOID RELEASE TO THE ENVIRONMENT. MATERIAL SAFETY DATA SHEET: REVIEWED CHEMICAL COMPOSITION AND FLAMMABILITY INFORMATION, AND ALL INGREDIENTS USED PER SPECIFICATION. THERE WAS POSSIBLE MIX UP OF INGREDIENTS (FINISHED PRODUCT CONCENTRATE WAS ANALYSED UPON COMPLETION OF EACH BATCH AND A REPEAT ANALYSIS WAS CARRIED OUT ON PRODUCT TAKEN FROM THE FILLING HEAD AT THE START OF EACH PRODUCTION RUN, TO ENSURE NO CROSS CONTAMINATION BETWEEN THE LAST AND NEW PRODUCT. NO EXPIRED MATERIAL WAS USED. LARGELY DUE THE VOLUME OF PRODUCT WE MANUFACTURE FOR CONVATEC AND OUR SITE LIMITS FOR STORING OF HIGHLY FLAMMABLE SOLVENT, THE TURNAROUND OF THE MATERIAL AT HYDROKEM WAS VERY SHORT. THE MATERIAL EXPIRY DATE PROVIDED BY THE MANUFACTURER WAS 12 MONTHS. TYPICALLY, THE TURN-AROUND OF HEXAMETHYLDISILOXANE (CONSUMER USE, PROFESSIONAL USE, INDUSTRIAL USE) WAS MEASURED IN DAYS. HEXAMETHYLDISILOXANE COULD CAUSE THE FIRE AND WAS THERE ANYTHING ABNORMAL DURING MANUFACTURING. OUR MANUFACTURING DATA FOR THE LAST 12 MONTHS FOR BOTH THE ADHESIVE REMOVE AND BARRIER FILM SHOWS NO ABNORMALITIES ASSOCIATED WITH THE FORMULATION. NO CHEMICAL INSTABILITY/CONTAMINATION, BASED ON ANALYTICAL EVALUATION OF EVERY BATCH. THE PRODUCTS ARE SUPPLIED IN A BAG-ON-VALVE FORMAT. THE ¿DRIVE¿ GAS, WHICH WAS CONTAINED IN THE OUTER COMPARTMENT OF THE CAN WAS COMPRESSED AIR (NON-FLAMMABLE), HOWEVER, IT SHOULD BE NOTED THAT THE COMPRESSED AIR WAS NOT EMITTED FROM THE CAN DURING USE BUT REMAINS PERMANENTLY INSIDE THE CAN. ONLY THE FINISHED PRODUCT CONCENTRATE WAS EMITTED FROM THE CAN. SPRAY MECHANISM INSPECTION: OVER MANY YEARS OF FILLING THIS TYPE OF PRODUCT, THE PRIMARY, POTENTIAL ISSUE, WHICH WAS AT A VERY LOW LEVEL, WAS THE FAILURE OF THE BAG-ON-VALVE SEAM INSIDE THE CAN. THIS TYPICALLY RESULTS IN VERY WEAK OR IN SOME INSTANCES, FAILURE TO SPRAY AND WOULD NOT BE CONSIDER A RISK TO INCREASED POTENTIAL TO IGNITE. ALL COMPONENTS ARE SUBJECT TO INCOMING GOODS INSPECTION AND HOURLY ON-LINE CHECKS (FOR A NUMBER OF FACTORS INCLUDING SPRAY PERFORMANCE) ARE CARRIED OUT THROUGHOUT THE PRODUCTION RUNS. THE PRODUCT CAN POTENTIALLY BE IGNITED BY MANY IGNITION SOURCES, AS IT WAS HIGHLY FLAMMABLE. THIS WOULD INCLUDE A DIRECT IGNITION SOURCE, SUCH AS A NAKED FLAME OF USE OF VARIOUS MEDICAL EQUIPMENT INCLUDING CAUTERISING OR COULD BE A STATIC DISCHARGE FROM A PLASTIC APRON IF THE PERSON WAS NOT EARTHED. TO PROVIDE AN INDICATION OF WHAT WAS THE POTENTIAL IGNITION SOURCE, IT WAS THEREFORE, NECESSARY TO UNDERSTAND THE EXACT CIRCUMSTANCES THE PRODUCT HAS BEEN USED AND THE SURROUNDING ENVIRONMENT. NO FORMULA CHANGED RECENTLY IN ANY WAY (INGREDIENTS, PRESSURE, PACKAGING). TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092, THIRD PARTY MANUFACTURING SITE: 3010605379.