SNAP¿ 125MMHG THERAPY CARTRIDGE

Additional Manufacturer Narrative

BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED MACERATION, SLOUGH AND BLISTERING ARE RELATED TO SNAP¿ 125MMHG THERAPY CARTRIDGE. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: IF A WOUND HAS BEEN PROGRESSING WELL FROM DRESSING CHANGE TO DRESSING CHANGE BUT THEN DETERIORATES RAPIDLY, CONSIDER THE FOLLOWING INTERVENTIONS AND, WHERE NECESSARY, SEEK THE GUIDANCE/EXPERTISE OF A SPECIALIST: CHECK THE THERAPY HOUR METER TO ENSURE THAT THE ACTUAL NUMBER OF THERAPY HOURS RECEIVED MATCHES THE NUMBER OF RECOMMENDED THERAPY HOURS (22 HOURS A DAY). IF THE NUMBER OF THERAPY HOURS IS LESS THAN 22 EACH DAY, FIND OUT WHY THERE IS A THERAPY DEFICIT AND REMEDY THE SITUATION. CLEAN WOUND MORE THOROUGHLY DURING DRESSING CHANGES. EVALUATE FOR SIGNS AND SYMPTOMS OF INFECTION AND, IF PRESENT, TREAT ACCORDINGLY. CHANGE DRESSING OFTEN, ENSURING THAT IT IS BEING CHANGED AT LEAST EVERY 48 HOURS. EXAMINE THE WOUND AND DEBRIDE AS NECESSARY. DEBRIDE THE WOUND EDGES IF THEY APPEAR NON-VIABLE OR ROLLED UNDER AS THIS MAY INHIBIT THE FORMATION OF GRANULATION TISSUE AND MIGRATION OF EPITHELIAL CELLS OVER AN ACCEPTABLE WOUND BASE.

Description of Event or Problem

ON (B)(6) 2019, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PHYSICIAN: THE PATIENT ALLEGEDLY EXPERIENCED A TECHNICAL ISSUE WITH SNAP¿ THERAPY, AND THE PATIENT EXPERIENCED WOUND MACERATION, PERIWOUND BLISTERING, "SLOUGHY" WOUND BED WITH A "BAD WOUND OUTCOME." ON 26-JUN-2019, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PHYSICIAN: ON (B)(6) 2019, SNAP¿ THERAPY SYSTEM WAS APPLIED. ON (B)(6) 2019, THE PATIENT EXPERIENCED A LOT OF DRAINAGE FROM THE WOUND, AND THE DRESSING REPORTEDLY DID NOT ADHERE. THE SNAP¿ THERAPY SYSTEM ALLEGEDLY HAD NOT INDICATED THAT A TECHNICAL ISSUE OCCURRED. UPON COMPLETE DRESSING REMOVAL, THE SNAP¿ THERAPY SYSTEM ALLEGEDLY DID NOT INDICATE ANY SIGN OF LEAKAGE. THE PHYSICIAN NOTED THAT THE DUE TO THE VOLUME OF EXUDATE, THE PATIENT EXPERIENCED MACERATION AND PERIWOUND BLISTERS. THE PATIENT SUBSEQUENTLY UNDERWENT A DRAINAGE OF THE BLISTER AND A DEBRIDEMENT. THE PHYSICIAN REPORTED THAT PATIENT HAS PERIPHERAL VASCULAR DISEASE AND WAS CONCERNED THE WOUND "MIGHT DETERIORATE" BUT CONFIRMED THE WOUND HEALED. THE SNAP¿ 125MMHG THERAPY CARTRIDGE WAS NOT RETURNED, THEREFORE A DEVICE EVALUATION COULD NOT BE PERFORMED. A DEVICE HISTORY REVIEW OF SNAP¿ 125MMHG THERAPY CARTRIDGE LOT NUMBER 5549875V001 DETERMINED THAT NO NONCONFORMANCES WERE IDENTIFIED NOR DEVIATIONS USED DURING THE MANUFACTURE OF THIS LOT. ALL END RELEASE TESTING OF PRODUCT AND PACKAGING MET SPECIFICATIONS. THE SNAP¿ DRESSING LOT NUMBER WAS NOT PROVIDED, THEREFORE, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.