BLUE COMFORT BOUFFANT 24 IN

Additional Manufacturer Narrative

MULTIPLE ATTEMPTS TO OBTAIN SAMPLES FROM THE CUSTOMER WERE MADE AND THE SAMPLES HAVE JUST BEEN RECEIVED. THEREFORE; A FOLLOW UP REPORT WILL BE FILED ONCE THE SAMPLE EVALUATION HAS BEEN COMPLETED.

Description of Event or Problem

THE PATIENT HAS ALLERGY CONDITIONS AND DEVELOPED A RASH AROUND HER HAIRLINE WHERE THE CAP FIT. CAPS ARE LATEX FREE.

Additional Manufacturer Narrative

THE CUSTOMER'S SAMPLE WAS RECEIVED FOR EVALUATION. A REVIEW OF THE RETURNED SAMPLE DID NOT INDICATE ANY ABNORMAL FINDINGS THAT WOULD RESULT IN THE ALLERGIC REACTION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED AS NO LOT NUMBER WAS PROVIDED. A REVIEW OF RAW MATERIAL RECORDS FOR THE CURRENT PRODUCTION INDICATED THAT THE MATERIAL USED WAS APPROVED AND IN COMPLIANCE WITH THE REQUIRED SPECIFICATIONS. THE MATERIAL USED FOR THE BOUFFANT IS POLYPROPYLENE WITH CALCIUM CARBONATE FILLERS, WHICH PASSED THE BIOCOMPATIBILITY TESTS PRESCRIBED BY THE REGULATORY AGENCY FOR THE INTENDED USE. THERE WERE NO CHANGES TO THE MATERIAL COMPOSITION INCLUDING ELASTIC AND THREAD. THEREFORE, BASED ON THESE FINDINGS WE ARE UNABLE TO DETERMINE THE ROOT CAUSE FOR THE ISSUE REPORTED. NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR ANY SIMILAR REPORTS.