FDA Adverse Event
Injury
Summary report: N
IDEAL IMPLANT STRUCTURED BREAST IMPLANT
MDR report key: 11968221
·
Received June 9, 2021
Report
- Report Number
- 3011491947-2021-00152
- Event Type
- Injury
- Date Received
- June 9, 2021
- Date of Event
- June 1, 2021
- Report Date
- June 9, 2021
- Manufacturer
- IDEAL IMPLANT
- Product Code
- FWM
- UDI-DI
- 10851795006091
- PMA / PMN Number
- P120011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 0
MACROSCOPIC AND MICROSCOPIC EXAMINATION OF THE EXPLANTED DEVICE REVEALED A MINUTE PARTICLE OF CURED SILICONE WITHIN THE SHELL CAUSING OUTER SHELL FAILURE AND DEFLATION. UPDATE/CORRECTION TO SECTIONS B5, D9, G3, G6, H2, H3, H6 AND H10
Description of Event or Problem · 0
DEFLATION RESULTING IN EXPLANTATION
Description of Event or Problem · 1
ALLEGED DEFLATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 867339 | IDEAL IMPLANT STRUCTURED BREAST IMPLANT | SALINE-FILLED BREAST IMPLANT | FWM | IDEAL IMPLANT | 51501 | 63342 | 10851795006091 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Required Intervention |