FDA Adverse Event
Injury
Summary report: N
SALINE BREAST IMPLANTS
MDR report key: 1760826
·
Received July 1, 2010
Report
- Report Number
- 1760826
- Event Type
- Injury
- Date Received
- July 1, 2010
- Date of Event
- June 25, 2010
- Report Date
- July 1, 2010
- Manufacturer
- UNKNOWN
- Product Code
- FWM
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
SALINE BREAST IMPLANT DEFLATED. IMPLANT REMOVED AND REPLACED BY PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SALINE BREAST IMPLANTS | NONE | FWM | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |