FDA Adverse Event Summary report: N

MAMMARY PROSTHESIS

MDR report key: 13309 · Received May 18, 1994

Report

Report Number
MW1002067
Date Received
May 18, 1994
Report Date
May 5, 1994
Manufacturer
MCGHAN MEDICAL CORP.
Product Code
FTR
Report Source
Voluntary report
Reporter Location
SC, US
Reporter Occupation
ATTORNEY

Narratives

Description of Event or Problem · 1

PT COMPLAINS OF ACHES AND PAINS, PAINFUL BREASTS, ITCHING, SWELLING OF JOINTS, HANDS AND FEET, FATIGUE, HEAVY MENSTRUAL BLEEDING, FIBROSIS, INFECTIONS, AND FIBROMYALGIA. (SAME PT REFERRED TO IN 1002066.)

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MAMMARY PROSTHESIS FTR MCGHAN MEDICAL CORP.

Patients

Seq Age Sex Outcome Treatment
1 *