FDA Adverse Event Injury Summary report: N

APHI

MDR report key: 293342 · Received August 30, 2000

Report

Report Number
2125050-2000-00009
Event Type
Injury
Date Received
August 30, 2000
Date of Event
July 11, 2000
Report Date
August 30, 2000
Manufacturer
MENTOR CORPORATION - MINNESOTA DIVISION
Product Code
FWN
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
FL, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

FAILED PENILE PROSTHESIS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 APHI INFLATABLE PENILE PROSTHESIS FWN MENTOR CORPORATION - MINNESOTA DIVISION NI NI

Patients

Seq Age Sex Outcome Treatment
1 67 YR Hospitalization| R