FDA Adverse Event
Injury
Summary report: N
UNK STYLE SCX
MDR report key: 20024992
·
Received August 22, 2024
Report
- Report Number
- 9617229-2024-19083
- Event Type
- Injury
- Date Received
- August 22, 2024
- Report Date
- August 19, 2024
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
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. FOLLOW-UP IS NOT POSSIBLE WITH THE INITIAL REPORTER, THEREFORE ADDITIONAL EVENT, PRODUCT, AND/OR PATIENT DETAILS ARE NOT ATTAINABLE. THE REASON FOR REOPERATION IS: "CAPSULAR CONTRACTURE BAKER GRADE III".
Description of Event or Problem · 0
ALLERGAN AESTHETICS RECEIVED A REPORT VIA NBIR OF A RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III". THE DEVICE WAS EXPLANTED AND REPLACED. A CAPSULECTOMY/CAPSULOTOMY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1128508 | UNK STYLE SCX | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |