NON-ALLERGAN BREAST IMPLANT
Report
- Report Number
- 9617229-2024-16577
- Event Type
- Injury
- Date Received
- July 10, 2024
- Date of Event
- April 18, 2024
- Report Date
- September 9, 2024
- Manufacturer
- NON-ALLERGAN
- Product Code
- FWM
- PMA / PMN Number
- P990074
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE AFFECTED DEVICE HAS BEEN CONFIRMED AS NON-ALLERGAN AND THIS REPORT IS NO LONGER CONSIDERED REPORTABLE TO THE FDA.
THE EVENT OF CAPSULAR CONTRACTURE IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON FOR REOPERATION IS: "CAPSULAR CONTRACTURE, BAKER GRADE III" AND "EXCHANGE OF TEXTURED DEVICES DUE TO PATIENT'S CONCERN WITH PRODUCT."
THE AFFECTED DEVICE HAS BEEN CONFIRMED AS NON-ALLERGAN AND THIS REPORT IS NO LONGER CONSIDERED REPORTABLE TO THE FDA.
THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III" AND "EXCHANGE OF TEXTURED DEVICES DUE TO PATIENT'S CONCERN WITH PRODUCT." RECORD IS FOR LEFT SIDE. DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 364161 | NON-ALLERGAN BREAST IMPLANT | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | NON-ALLERGAN | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Female | Required Intervention |