FDA Adverse Event
Death
Summary report: N
UNK GEL BREAST IMPLANT
MDR report key: 15112758
·
Received July 27, 2022
Report
- Report Number
- 9617229-2022-13071
- Event Type
- Death
- Date Received
- July 27, 2022
- Manufacturer
- UNKNOWN MANUFACTURER
- Product Code
- FTR
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE EVENT OF DEATH IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. NO CONTACT INFORMATION WAS PROVIDED FOR THE INITIAL REPORTER, THEREFORE ADDITIONAL EVENT, PRODUCT, AND/OR PATIENT DETAILS ARE NOT ATTAINABLE. REASON FOR REOPERATION: "DEAD FROM SILICONE POISONING".
Description of Event or Problem · 0
PATIENT REPRESENTATIVE REPORTED VIA SOCIAL MEDIA POST "DEAD FROM SILICONE POISONING." THE MANUFACTURE OF THE DEVICE IS UNKNOWN. LEFT SIDE DEVICE STATUS IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2137805 | UNK GEL BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | UNKNOWN MANUFACTURER | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Death |