INSTA GARD YELLOW ISOLATION MASK

Description of Event or Problem

A RESPIRATORY THERAPIST DEVELOPED A RASH WITH SEVERE ITCHING. THE RASH LOOKED SIMILAR TO HIVES, AND SPREAD TO HER NECK/CHEST/UPPER BACK/UPPER ARMS. SHE SAW SEVERAL PHYSICIANS AND RECEIVED TREATMENT AND WAS GIVEN MEDICATIONS. PRESENTLY, SHE IS NOT HAVING ANY PROBLEMS.

Additional Manufacturer Narrative

THE LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. NO SAMPLE WAS PROVIDED. WITHOUT THE LOT NUMBER OR THE SAMPLE, WE ARE UNABLE TO ASSIGN A ROOT CAUSE. DURING THE PRODUCT DEVELOPMENT PHASE, ALL MATERIALS USED IN THIS MASK WERE EVALUATED FOR BIOCOMPATIBILITY. THE TESTING WAS PERFORMED IN ACCORDANCE WITH INTERNATIONAL STANDARD IOS 10993 BIOLOGICAL EVALUATION OF MEDICAL DEVICES. ONLY MATERIALS THAT SUCCESSFULLY COMPLETE THESE TESTS CAN BE COMMERCIALIZED. THE TESTS UTILIZED ARE DESIGNED TO PREDICT THE SAFETY OF THE PRODUCT FOR THE GENERAL POPULATION OF USERS. UNFORTUNATELY NO TEST OR SERIES OF TESTS CAN GUARANTEE THAT A PARTICULAR ITEM WILL BE COMPATIBLE WITH ALL USERS. NO CHANGES HAVE BEEN MADE IN THE MANUFACTURING PROCESS FOR THIS PRODUCT THAT WOULD ACCOUNT FOR THIS TYPE OF EVENT. WE WILL CONTINUE TO MONITOR FOR COMPLAINTS OF THIS NATURE.