UNK MAMMARY IMPLANT
Report
- Report Number
- 9617229-2024-00311
- Event Type
- Injury
- Date Received
- January 5, 2024
- Report Date
- January 4, 2024
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FWM
- PMA / PMN Number
- P990074
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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 REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN.
PLEASE SEE MDR 9617229-2024-00140-00 AS OPERATING RECORD FOR THIS COMPLAINT.
PATIENT REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.
PREVIOUS MEDWATCH SUBMISSION NOTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN TO LEFT SIDE. UPON FURTHER INFORMATION, ABBVIE HAS DETERMINED THAT THIS RECORD IS AN UNKNOWN AFFECTED SIDE. THIS COMPLAINT HAS BEEN PREVIOUSLY CAPTURED UNDER MDR 9617229-2024-00140-00 AND WILL REMAIN TO BE THE OPERATING RECORD FOR THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 655089 | UNK MAMMARY IMPLANT | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | ALLERGAN (COSTA RICA) | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |