FDA Adverse Event
Death
Summary report: N
STYLE 68 SALINE FILLED BREAST IMPLANT
MDR report key: 5061176
·
Received September 8, 2015
Report
- Report Number
- 9617229-2015-00319
- Event Type
- Death
- Date Received
- September 8, 2015
- Date of Event
- June 22, 2011
- Report Date
- June 22, 2011
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FWM
- PMA / PMN Number
- P990074
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MEDWATCH SUBMITTED TO THE FDA ON (B)(6) 2015.
Description of Event or Problem · 1
CLINICAL RESEARCH ORGANIZATION REPORTED PATIENT'S DEATH DUE TO "NDI -J189- PNEUMONIA, UNSPECIFIED" WHICH WAS RECEIVED VIA A "(B)(6)." FOLLOW-UP WITH THE PHYSICIAN'S OFFICE AND PATIENT'S LISTED CONTACT PERSON DID NOT RETURN ANY INFORMATION. CAUSALITY OF THE EVENTS REMAIN UNKNOWN. SIDE UNSPECIFIED. THIS MEDWATCH IS FOR THE LEFT SIDE. SEE MFR # 9617229-2015-00318 FOR THE RIGHT SIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 593147 | STYLE 68 SALINE FILLED BREAST IMPLANT | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | ALLERGAN (COSTA RICA) | 1625741 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Death |