FDA Adverse Event Injury Summary report: N

INFLATABLE PENILE PROSTHESIS

MDR report key: 8880 · Received July 22, 1993

Report

Report Number: 8880
Event Type: Injury
Date Received: July 22, 1993
Date of Event: September 26, 1992
Report Date: February 5, 1993
Manufacturer: AMERICAN MEDICAL SYSTEMS
Product Code: FAE
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

MAY 15, 1992, IMPLANTATION OF AMS ULTREX PENILE PROSTHESIS, DEVELOPED INFECTION, AS A RESULT THE RIGHT CYLINDER PERFORATED THE MEDICAL ASPECT OF THE OCRPORA INTO THE URETHRA. IMPLANT REMOVED SEPTEMBER 26, 1992. JANUARY 25, 1993 NEW CYLINDER IMPLANTED.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	Implant	INFLATABLE PENILE PROSTHESIS	FAE	AMERICAN MEDICAL SYSTEMS	AMS 700 CX	7355L-005

Patients

Seq	Age	Sex	Outcome	Treatment
1	71 YR		Other