N
Patient 1
UPON COMPLETION OF INVESTIGATION, ADDITIONAL INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
MAUDE MDR 8557907
- MDR report key
- 8557907
- Report number
- 0008031020-2019-00375
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-04-04
- Date received
- 2019-04-26
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. KEVIN SMITH
- Address
- 325 CORPORATE DRIVE MAHWAH NJ 07430 US
- Phone
- 201-201-2018
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 50 SILICONE PIP IMPLANT (STERILE PACKED) | PROSTHESIS, FINGER, CONSTRAINED, POLYMER | STRYKER GMBH | KYJ | PIP50 | UNKNOWN | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-04-26 | 0 | 1. R |
Event Narratives#
D
Patient 1
A SILICONE PIP REPLACEMENT NEEDED TO BE REPLACED BECAUSE OF WHAT LOOKS TO BE MATERIAL FATIGUE.