FDA Adverse Event
Injury
Summary report: N
MAMMARY IMPLANT
MDR report key: 26043
·
Received September 26, 1995
Report
- Report Number
- MW1007038
- Event Type
- Injury
- Date Received
- September 26, 1995
- Date of Event
- January 1, 1983
- Report Date
- September 17, 1995
- Manufacturer
- MCGHAN MEDICAL CORP.
- Product Code
- FTR
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
REPORTER COMPLAINS OF IMMUNE DISORDER, KIDNEY DISEASE, FIBROMYALGIA, CHRONIC MUSCLE AND JOINT PAIN, CHRONIC BREATHING PROBLEMS, CHRONIC MIGRAINE HEADACHES, FATIGUE, CHRONIC INFECTIONS, FREQUENT HOSPITALIZATIONS, RUPTURE (1988), IRRITABLE BOWEL. (ALSO SEE 100737, 100739).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAMMARY IMPLANT Implant | BREAST IMPLANT | FTR | MCGHAN MEDICAL CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Hospitalization| L| S |