FDA Adverse Event
Injury
Summary report: N
IDEAL IMPLANT STRUCTURED BREAST IMPLANT
MDR report key: 11857322
·
Received May 20, 2021
Report
- Report Number
- 3011491947-2021-00120
- Event Type
- Injury
- Date Received
- May 20, 2021
- Date of Event
- May 5, 2021
- Report Date
- June 17, 2021
- Manufacturer
- IDEAL IMPLANT
- Product Code
- FWM
- UDI-DI
- 10851795006053
- PMA / PMN Number
- P120011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 0
MACROSCOPIC AND MICROSCOPIC EXAMINATION OF THE EXPLANTED DEVICE REVEALED TEAR THROUGH THE SHELL RESULTING IN OUTER LUMEN DEFLATION.
Description of Event or Problem · 0
DEFLATION RESULTING IN EXPLANTATION OF IMPLANT.
Description of Event or Problem · 1
ALLEGED DEFLATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 750381 | IDEAL IMPLANT STRUCTURED BREAST IMPLANT | SALINE-FILLED BREAST IMPLANT | FWM | IDEAL IMPLANT | 37001 | 62329 | 10851795006053 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Required Intervention |