FDA Adverse Event Injury Summary report: N

SILICONE PROSTHESIS BREAST PROSTHESIS (CLOSING SEAL WITH INFORMATION ERASED BY T

MDR report key: 16853598 · Received May 1, 2023

Report

Report Number
MW5117181
Event Type
Injury
Date Received
May 1, 2023
Date of Event
July 21, 2022
Report Date
April 25, 2023
Manufacturer
UNK
Product Code
FTR
Adverse Event
Yes
Report Source
Voluntary report
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PATIENT WITH BREAST IMPLANTS 27 YEARS AGO DEVELOPED CARCINOMA IN THE CAPSULE. REFERENCE REPORT: MW5117182.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1740056 SILICONE PROSTHESIS BREAST PROSTHESIS (CLOSING SEAL WITH INFORMATION ERASED BY T PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR UNK

Patients

Seq Age Sex Outcome Treatment
1 64 YR Female Other