FDA Adverse Event
Malfunction
Summary report: N
NATRELLE
MDR report key: 3861261
·
Received May 29, 2014
Report
- Report Number
- 3861261
- Event Type
- Malfunction
- Date Received
- May 29, 2014
- Date of Event
- March 17, 2014
- Report Date
- May 29, 2014
- Manufacturer
- ALLERGAN
- Product Code
- FTR
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 317226 | NATRELLE | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FTR | ALLERGAN | 68MP | 1174755 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |