FDA Adverse Event
Injury
Summary report: N
UNK GEL BREAST IMPLANT
MDR report key: 8921910
·
Received August 22, 2019
Report
- Report Number
- 9617229-2019-12926
- Event Type
- Injury
- Date Received
- August 22, 2019
- Report Date
- August 22, 2019
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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: RUPTURE. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.
Description of Event or Problem · 1
PATIENT, THRU REGULATORY AGENCY, REPORTED RUPTURED IMPLANT AND SILICONE LEAKING, PAIN, SORENESS AND PAIN IN BREAST AREA, MUSCLE WEAKNESS, FLU SYMPTOMS. HEADACHES, NAUSEA, SORE THROAT, AND BREAST IMPLANT ILLNESS, CHRONIC FATIGUE, BRAIN FOG/COGNITIVE MEMORY ISSUES, FOOD INTOLERANCES AND IBS, CHRONIC BLADDER WEAKNESS, SENSITIVITY TO LIGHT AND SOUND. THIS RECORD REPRESENTS THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 716588 | UNK GEL BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |