D
Patient 1
THE CUSTOMER REPORTED MOLD ON THE WEDGIE PRODUCT. NO PT INCIDENT/INJURY WAS REPORTED.
MAUDE MDR 4309742
- MDR report key
- 4309742
- Report number
- 1218950-2014-07327
- Event key
- 0
- Event type
- 3
- Date received
- 2014-09-24
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- NANCY ATAIDE
- Address
- 3000 MINUTEMAN RD. ANDOVER MA 01810 US
- Phone
- 978-978-9786
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | WEDGIE - "3X4"X5" | PHILIPS MEDICAL SYSTEMS | FMP | 91014 | LOT CODE NOT PROVIDED - NO | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-09-24 | 0 |
Event Narratives#
N
Patient 1
(B)(4). THE CUSTOMER REPORTED MOLD ON THE WEDGIE PRODUCT. NO PT INCIDENT/INJURY WAS REPORTED. THIS COMPLAINT IS BEING REPORTER, 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.