FDA Adverse Event
Other
Summary report: N
PIP, INC.
MDR report key: 221186
·
Received April 8, 1999
Report
- Report Number
- 9681903-1999-00022
- Event Type
- Other
- Date Received
- April 8, 1999
- Date of Event
- February 5, 1999
- Report Date
- February 11, 1999
- Manufacturer
- PIP, INC.
- Product Code
- FWM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IMPLANT RUPTURE, CAUSE OF RUPTURE UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PIP, INC. Implant | BREAST IMPLANT | FWM | PIP, INC. | TEXTURED | 97232 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Other |