BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA I INFLATABLE PENILE PROSTHESIS

    MDR report key: 122484 · Received September 26, 1997

    Report

    Report Number
    2125050-1997-00504
    Event Type
    Injury
    Date Received
    September 26, 1997
    Date of Event
    April 4, 1997
    Report Date
    August 21, 1997
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 10/23/96 AND REMOVED ON 4/4/97 BECAUSE IT WAS "MALFUNCTIONING." IN THE REC'D INFO THE PHYSICIAN STATED THAT THE DEVICE WAS "NOT STAYING INFLATED." ADDITIONALLY THE INFO STATED THAT THE PT HAD "COMPLAINED OF VARIOUS DISCOMFORT OVER A PERIOD OF TIME." A PUMP, TWO CYLINDERS, AND A RESERVOIR WERE RETURNED FOR EVAL. REQUESTS HAVE BEEN MADE FOR ADD'L INFO SURROUNDING THE INCIDENT, HOWEVER, TO DATE THE REQUESTED INFO HAS NOT BEEN REC'D. WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE EVENTS SURROUNDING THE INCIDENT. SHOULD ADD'L INFO BE REC'D, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE WITH PROCEDURES. BECAUSE QA'S EXAMINATION OF THE RETURNED COMPONENTS CAN NEITHER CONFIRM NOR DISPROVE THE REPORT OF "DISCOMFORT" QA ACCEPTS THE PHYSICIAN'S OBSERVATIONS OF SUCH. EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED NO FUNCTIONAL ABNORMALITIES. BECAUSE NO FUNCTIONAL ABNORMALITIES WERE DETECTED QA CONCLUDED THAT NO FUNCTIONAL ABNORMALITIES CONTRIBUTED TO THE REPORTED EVENT. BECAUSE THE LIMITED INFO REC'D DOES NOT INDICATE WHAT FACTOR(S) MAY HAVE CONTRIBUTED TO THE DEVICE "NOT STAYING INFLATED," QA IS PRECLUDED FROM DETERMINING THE CAUSE OF THE REPORTED EVENT HOWEVER, DUE TO THE DEVICE WAS "NOT STAYING INFLATED." THE PRODUCT DATA SHEET THAT ACCOMPANIED THIS DEVICE INDICATES THAT INVOLUNATARY DEFLATIONS ARE A POTENTIAL INHERENT RISK WITH THE USE OF INFLATABLE PENILE IMPLANTS.

    Description of Event or Problem · 1

    PER THE INFO PROVIDED TO CO BY THE HOSPITAL, VIA MEDWATCH REPORT #17-0086-1997-0002, THE DEVICE WAS REMOVED DUE TO "MALFUNCTION." AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHA I INFLATABLE PENILE PROSTHESIS Implant INFLATABLE PENILE PROSTHESIS FHW MENTOR UROLOGY, INC. NA E90134/E90218/R90220

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention