FDA Adverse Event Injury Summary report: N

MARK II INFLATABLE PENILE PROSTHESIS

MDR report key: 77301 · Received March 19, 1997

Report

Report Number: 2125050-1997-00134
Event Type: Injury
Date Received: March 19, 1997
Date of Event: February 6, 1997
Report Date: March 19, 1997
Manufacturer: MENTOR UROLOGY, INC.
Product Code: FHW
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS REMOVED ON 2/6/97 DUE TO A "MALFUNCTION." NO INFO REGARDING THE IMPLANT SURGERY WAS PROVIDED. A RESIPUMP AND TWO CYLINDERS WERE RETURNED FOR EVALUATION. REQUESTS HAVE BEEN MADE FOR ADD'L INFO SURROUNDING THE INCIDENT, HOWEVER, TO DATE THE REQUESTED INFO HAS NOT BEEN RECEIVED. WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE EVENTS SURROUNDING THE INCIDENT. SHOULD ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE WITH PROCEDURES. EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED NO FUNCTIONAL ABNORMALITIES. BASED ON THIS QA CONCLUDED THAT NO FUNCTIONAL ABNORMALITIES CONTRIBUTED TO THE REPORTED EVENT. BECAUSE THE LIMITED INFO PROVIDED DIE NOT INDICATE WHAT FACTOR(S) MAY HAVE CONTRIBUTED TO THIS EVENT, QA IS PRECLUDED FROM DETERMINING THE CAUSE OF THE REPORTED "MALFUNCTION."

Description of Event or Problem · 1

THE DEVICE WAS REMOVED DUE TO A "MALFUNCTION." AS REPROTED TO CO, THE ENTIRE 2-PIECE INFLATABLE PENILE PROSTHESIS WAS REMOVED AND REPLACED WITH ANOTHER CO'S 2-PIECE INFLATABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MARK II INFLATABLE PENILE PROSTHESIS Implant	INFLATABLE PENILE PROSTHESIS	FHW	MENTOR UROLOGY, INC.	NA	E90054

Patients

Seq	Age	Sex	Outcome	Treatment
1	74 YR		Required Intervention