FDA Adverse Event
Injury
Summary report: N
STYLE 68 SALINE FILLED BREAST IMPLANT
MDR report key: 8696231
·
Received June 13, 2019
Report
- Report Number
- 9617229-2019-06099
- Event Type
- Injury
- Date Received
- June 13, 2019
- Date of Event
- May 15, 2019
- Report Date
- June 13, 2019
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FWM
- PMA / PMN Number
- P990074
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE AFFECTED SIDE OF THE DEFLATION IS UNKNOWN. THE SERIAL NUMBER FOR THE LEFT SIDE IS (B)(4) WITH LOT NUMBER 1299877, AND SERIAL NUMBER (B)(4) WITH LOT NUMBER 1180050 FOR THE RIGHT SIDE. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON FOR REOPERATION IS DEFLATION. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.
Description of Event or Problem · 1
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" OF A SALINE DEVICE. AFFECTED SIDE UNKNOWN. DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 487924 | STYLE 68 SALINE FILLED BREAST IMPLANT | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | ALLERGAN (COSTA RICA) | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |