FDA Adverse Event
Injury
Summary report: N
IDEAL IMPLANT STRUCTURED BREAST IMPLANT
MDR report key: 12001687
·
Received June 15, 2021
Report
- Report Number
- 3011491947-2021-00160
- Event Type
- Injury
- Date Received
- June 15, 2021
- Date of Event
- June 1, 2020
- Report Date
- June 14, 2021
- Manufacturer
- IDEAL IMPLANT INCORPORATED
- Product Code
- FWM
- UDI-DI
- 10851795006084
- PMA / PMN Number
- P120011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DEFLATION REPORTED AS THE REASON FOR EVENT COMPLICATION. DEVICE NOT AVAILABLE FOR EVALUATION DUE TO DEVICE NOT EXPLANTED.
Description of Event or Problem · 0
ALLEGED DEFLATION.
Description of Event or Problem · 1
ALLEGED DEFLATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 893702 | IDEAL IMPLANT STRUCTURED BREAST IMPLANT | SALINE-FILLED BREAST IMPLANT | FWM | IDEAL IMPLANT INCORPORATED | 47501 | 62498 | 10851795006084 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Unknown | Required Intervention |