FDA Adverse Event
Injury
Summary report: N
UNK STYLE SCX
MDR report key: 13117677
·
Received December 30, 2021
Report
- Report Number
- 9617229-2021-52255
- Event Type
- Injury
- Date Received
- December 30, 2021
- Report Date
- December 30, 2021
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
NO CONTACT INFORMATION WAS PROVIDED FOR THE INITIAL REPORTER, THEREFORE ADDITIONAL EVENT, PRODUCT, AND/OR PATIENT DETAILS ARE NOT ATTAINABLE. 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. REASON FOR REOPERATION: CAPSULAR CONTRACTURE, BAKER GRADE III.
Description of Event or Problem · 0
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2019553 | UNK STYLE SCX | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |