FDA Adverse Event
Injury
Summary report: N
INAMED AESTHETICS OR MCGHAN 68 BREAST IMPLANT 300 CC SALINE-FILLED
MDR report key: 1982211
·
Received February 3, 2011
Report
- Report Number
- MW5019307
- Event Type
- Injury
- Date Received
- February 3, 2011
- Date of Event
- March 7, 2008
- Report Date
- February 3, 2011
- Manufacturer
- INAMED AESTHETICES
- Product Code
- FWM
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- VA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I SUFFER FROM SEVERE FACIAL PAIN. ATYPICAL FACIAL PAIN IS THE DIAGNOSIS AND IT IS A NEUROLOGICAL DISORDER. THIS NEUROLOGICAL DISORDER RESULTED IN ME HAVING ALL OF MY TEETH EXTRACTED AS I WAS DESPERATE TO END THE PAIN AND I THOUGHT IT WAS RELATED TO MY TEETH. I ALSO SUFFER FROM CHRONIC FATIGUE, CHRONIC BACTERIAL VAGINOSIS, AND SEVERE DEPRESSION. REASON FOR USE: ELECTIVE COSMETIC PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INAMED AESTHETICS OR MCGHAN 68 BREAST IMPLANT 300 CC SALINE-FILLED | INAMED DEVICE | FWM | INAMED AESTHETICES | 68 | 1258551 12054335 | |
| 2 | INAMED AESTHETICS OR MCGHAN 68 BREAST IMPLANT 300 CC SALINE-FILLED | INAMED DEVICE | FWM | INAMED AESTHETICES | 68 | 1263238 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Other| R |