BLUE COMFORT BOUFFANT 24 IN
Received Oct 23, 2015 · Event occurred Sep 29, 2015
Report 1423537-2015-00069 · MDR key 5171579
Device
Generic name
Blue Comfort Bouffant 24 In
Manufacturer
Cardinal Health Singapore 225 Pte LtdModel number
3274Catalog number
3274
Lot number
15EFB131
Product problems
- Insufficient Device Problem Information
Patient
44 YR
- Itching Sensation
Narrative
Additional Manufacturer Narrative
(B)(4). THE DEVICE HISTORY REPORT REVIEW DID NOT INDICATE ANY EXCEPTION THAT COULD LEAD TO THE REPORTED INCIDENT. REVIEW OF THE RAW MATERIALS INDICATED THAT THE MATERIALS, INCLUDING THE MAIN FABRICS AND ELASTICS, WERE FROM APPROVED SOURCE WHICH HAD BEEN SUBJECTED TO THE BIOCOMPATIBILITY TESTS FOR THE INTENDED USE. THERE WERE NO RECORDS OF CHANGES TO THE MATERIAL COMPOSITION AND PROCESS THAT COULD LEAD TO THE REPORTED INCIDENT. REVIEW OF THE RETURNED SAMPLES CONFIRMED THAT THE MATERIALS USED WERE CONSISTENT WITH OUR EXISTING PRODUCTION MATERIALS AND THEREFORE MET PRODUCT SPECIFICATIONS. FROM THE INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem
A REGISTERED NURSE COMPLAINED OF ITCHINESS- POSSIBLE ALLERGY.