WEDGIE - 3"X4"X5"
Received Sep 24, 2014
Report 1218950-2014-07325 · MDR key 4309743
Device
Product problems
- Contamination
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED MOLD ON THE WEDGIE PRODUCT. THERE WAS NO REPORTED PT INCIDENT/INJURY.
Additional Manufacturer Narrative
(B)(4). THE CUSTOMER REPORTED MOLD ON THE WEDGIE PRODUCT. NO PT INCIDENT/INJURY WAS REPORTED. THIS COMPLAINT IS BEING REPORTED, AS NO MATERIAL IS AVAILABLE FOR EVAL TO CONFIRM THAT THERE IS NO MOLD IN/ON THE PRODUCT. THERE IS NO CURRENT EVIDENCE THAT MOLD WILL GROW INSIDE THE WEDGIE PRODUCT (GEL MATRIX). THERE IS NO EVIDENCE OF GEL "SWEATING" THROUGH THE BLADDER FOR MOLD TO GROW ON THE OUTSIDE OF THE BLADDER. THE BLADDER IS MADE OF VINYL, WHICH IS A DIFFERENT MATERIAL FROM THAT USED FOR THE GEL-E DONUT PRODUCT. NO PRODUCT MALFUNCTION CAN BE CONFIRMED/DETERMINED, AS NO MATERIAL IS AVAILABLE FOR EVAL/TESTING.