FDA Adverse Event Injury Summary report: N

COMB, GEL-INF. MAMMARY PROSTHESIS

MDR report key: 89564 · Received May 7, 1997

Report

Report Number
6000001-1997-00529
Event Type
Injury
Date Received
May 7, 1997
Date of Event
March 8, 1984
Report Date
April 9, 1997
Manufacturer
AMERICAN HEYER-SCHULTE
Product Code
FTR
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
TX, US
Reporter Occupation
ATTORNEY

Narratives

Description of Event or Problem · 1

PLAINTIFF ALLEGES VARIOUS ILLNESSES INCLUDING, BUT NOT LIMITED TO, PAIN AND SUFFERING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 COMB, GEL-INF. MAMMARY PROSTHESIS Implant BREAST IMPLANT FTR AMERICAN HEYER-SCHULTE UNK *

Patients

Seq Age Sex Outcome Treatment
1 UNKNOWN Other