FDA Adverse Event
Injury
Summary report: N
MEMORYSHAPE (SILICONE) SILTEX MEDIUM HEIGHT
MDR report key: 5008441
·
Received August 10, 2015
Report
- Report Number
- 1645337-2015-00150
- Event Type
- Injury
- Date Received
- August 10, 2015
- Report Date
- August 10, 2015
- Manufacturer
- M
- Product Code
- FTR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 1
Narratives
Description of Event or Problem · 1
PT'S HUSBAND REPORTED THAT SHE HAS FIBROMYALGIA, ADDED AUTO-IMMUNE LIKE SYMPTOMS. POSSIBLY "DR. (B)(6)" DIAGNOSED FIBROMYALGIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 522873 | MEMORYSHAPE (SILICONE) SILTEX MEDIUM HEIGHT | MEMORY SHAPE PROSTHESES | FTR | M | 267729 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |