FDA Adverse Event
Injury
Summary report: N
STYLE 68 SALINE FILLED BREAST IMPLANT
MDR report key: 10332827
·
Received July 28, 2020
Report
- Report Number
- 9617229-2020-11351
- Event Type
- Injury
- Date Received
- July 28, 2020
- Date of Event
- June 9, 2020
- Report Date
- September 11, 2020
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FWM
- UDI-DI
- 10888628000445
- PMA / PMN Number
- P990074
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
DEVICE EVALUATION: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED DEVICE PATCH WITH LOT NUMBER 3061059 AND CATALOG NUMBER 68HP-500, WITHOUT FLUIDS. DEVICE ANALYSIS PERFORMED THROUGH PHOTOGRAPHS, DUE TO THE IMPOSSIBILITY TO PERFORM MICROSCOPIC ANALYSIS IT IS NOT POSSIBLE TO DETERMINE THE MOST LIKELY FAILURE MODE.
Description of Event or Problem · 0
HEALTHCARE PROFESSIONAL REPORTED "RIGHT LEAK AT VALVE WITH FOLD FLAW HOLE PERIPHERY".
Additional Manufacturer Narrative · 1
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCE NOTED. 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: DEFLATION.
Description of Event or Problem · 1
PATIENT REPORTED RIGHT SIDE "DEFLATION". DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 799712 | STYLE 68 SALINE FILLED BREAST IMPLANT | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | ALLERGAN (COSTA RICA) | 68HP-500 | 3061059 | 10888628000445 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Required Intervention |