D
Patient 1
THE CUSTOMER REPORTED THAT THE SURGERY DEPARTMENT DISCOVERED 2 SMALL BLACK SPOTS ON PRODUCT. THERE WAS NO REPORTED PT INCIDENT/INJURY.
MAUDE MDR 4309744
- MDR report key
- 4309744
- Report number
- 1218950-2014-07323
- 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 | GEL-E DONUT - MEDIUM | PHILIPS MEDICAL SYSTEMS | FMP | 92025-C | USE BY DATE OF 2015-02-09 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-09-24 | 0 |
Event Narratives#
N
Patient 1
(B)(4). QTY SURGERY DEPARTMENT DISCOVERED 2 SMALL BLACK PORTS ON IT. THERE WAS NO REPORTED PT INCIDENT/INJURY. THE 92025-C GEL-E DONUT WAS EVALUATED. THE 92025-C GEL-E DONUT FUNCTIONED AS DESIGNED. REPLACEMENT 92025-C GEL-E DONUT WAS ORDERED AND SHIPPED TO THE CUSTOMER SITE. RETURNED 92025-C GEL-E DONUT WILL BE SCRAPED AFTER THE EVAL HAS BEEN COMPLETED. THERE WAS NOT A PRODUCT MALFUNCTION, FOUND TO BE PERFORMING AS DESIGNED. NO FORMAL RESPONSE WAS REQUESTED AND NONE IS WARRANTED.