BLUE COMFORT BOUFFANT 24 IN
Received Oct 18, 2018 · Event occurred Sep 12, 2018
Report 1423537-2018-00243 · MDR key 7981447
Device
Generic name
Cap, Surgical
Manufacturer
Hubei Safeway Protective ProductsModel number
3274Catalog number
3274
Lot number
NA
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Skin Irritation
- Skin Irritation
Narrative
Additional Manufacturer Narrative
BASED ON THE SUPPLIER¿S INVESTIGATION, THE DEVICE HISTORY RECORD REVIEW DID NOT INDICATE ANY EXCEPTION THAT COULD LEAD TO THE REPORTED INCIDENT. THERE WAS NO CHANGE IN THE MATERIAL COMPOSITION. ONE BOUFFANT WAS RETURNED FOR VISUAL INSPECTION, THERE WAS NO ABNORMALITY FOUND. CONSIDERING THE COMPLAINT DEFECT CATEGORY OF IRRITATION, THE SUPPLIER REVIEWED THE RAW MATERIAL AND COMPONENT INSPECTION RECORD AND THEIR EXISTING MATERIAL USED FOR THIS CODE 3274, COMPLIES TO THE SPECIFICATION AND NO EXCEPTION WAS DETECTED THAT COULD RESULT IN THIS REPORTED ISSUE. THE ELASTIC MATERIAL USED FOR THE CAP PASSED BIO-COMPATIBILITY TESTS REQUIRED BY THE REGULATORY AGENCY FOR THE INTENDED USE. BASED ON THE INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT INFORMATION WAS PROVIDED TO THE RELEVANT SECTORS FOR THEIR AWARENESS. THERE IS NO ADDITIONAL ACTION TAKEN AT THIS TIME, BUT THE SUPPLIER WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.
Description of Event or Problem
THE END USER-CLINICIAN EXPERIENCED RASH FROM THE ELASTIC ON BOUFFANT CAP ON FOREHEAD.