FDA Adverse Event
Injury
Summary report: N
AMERICAN HEYER-SCHULTE GEL-FILLED MAMMARY PROSTHESIS
MDR report key: 27566
·
Received October 30, 1995
Report
- Report Number
- MW1007501
- Event Type
- Injury
- Date Received
- October 30, 1995
- Report Date
- August 19, 1995
- Manufacturer
- BAXTER V. MUELLER
- Product Code
- FTR
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
BLOOD IN URINE SINCE 1986, STIFF JOINTS IN HANDS, KNEES, ANKLES, FATIGUE, HAND SWELLING, HEADACHES, STIFF NECK, DRY MOUTH, FINGER ITCHING, DEPRESSION, MEMORY LOSS, HARD TIME CONCENTRATING, ANKLES AND KNEES TENDER TO TOUCH. SHE HAS BEEN DIAGNOSED WITH MYALGIAS (GROUP II), ARTHRALGIAS (GROUP III), CHRONIC FATIGUE (GROUP III), SLEEP DISTURBANCE (GROUP III), NIGHT SWEATS (GROUP III), & COGNITIVE DYSFUNCTION WITH DEPRESSION SEVERE ENOUGH TO INTERFERE WITH CONCENTRATION/SHORT TERM MEMORY AND TO REQUIRE HOSPITALIZATION. (*)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMERICAN HEYER-SCHULTE GEL-FILLED MAMMARY PROSTHESIS | MAMMARY PROSTHESIS | FTR | BAXTER V. MUELLER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Disability |