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