BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA I INFLATABLE PENILE PROSTHESIS

    MDR report key: 127829 · Received October 24, 1997

    Report

    Report Number
    2125050-1997-00555
    Event Type
    Injury
    Date Received
    October 24, 1997
    Date of Event
    September 24, 1997
    Report Date
    September 24, 1997
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 8/21/1995 AND REVISED ON 9/24/1997 BECAUSE IT WAS NOT FUNCTIONING AS INTENDED. PUMP WAS RETURNED FOR EVAL. REQUESTS HAVE BEEN MADE FOR ADDITIONAL INFO SURROUNDING INCIDENT, HOWEVER, TO DATE REQUESTED INFO HAS NOT BEEN RECEIVED. WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE EVENTS SURROUNDING INCIDENT. SHOULD ADDITIONAL INFO BE RECEIVED, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE WITH PROCEDURES. EXAMINATION AND TESTING OF THE RETURNED COMPONENT REVEALED A SEPARATION/LEAKAGE SITE ANTERIORLY IN THE SERIALIZED OUTLET'S STRAIN RELIEF. EXAMINATION OF SURFACES OF SEPARATION REVEALED MARKINGS CHARACTERISTIC OF SRESS(S) INDUCED RENDING. OPPOSITE THE SEPARATION, AT THE STRAIN RELIEF/TUBE JUNCTION A CREASE MARK IS NOTED WITHIN A CONFINED AREA OF ABRASION. ALL OF THE EXITING TUBINGS ARE NOTED TO CURVE TOWARD THE POSTERIOR. BASED ON QA'S EXAMINATION AND LIMITED INFO PROVIDED, QA CONCLUDED THAT WHILE IN-VIVO THE SERIALIZED OUTLET WAS BENT TOWARD THE POSTERIOR, PARTIALLY KINKED, AND ABRADING AGAINST ITSELF. QA FURTHER CONCLUDED THAT THIS POSITIONING, IN COMBINATION WITH DEVICE USAGE OVER TIME, CONTRIBUTED TO SUFFICIENT STRESS(S) TO REND THE STRAIN RELIEF AT THE NOTED SITE. THIS RENT WOULD ALLOW THE LOSS OF FLUID AND RENDER THE DEVICE INOPERABLE. PUMP COMPONENT WAS SOLE ITEM RECEIVED AND WAS THEREFORE DETACHED FROM ANY OTHER COMPONENTS. EXAMINATION OF INSTRUMENTATION ACROSS THE ENTIRE CROSS SECTIONAL SURFACE. BECAUSE THERE COMPONENTS WERE RELEASED ACCORDING TO MFG AND QUALITY CONTROL PROCEDURES, QA CONCLUDED THAT OBSERVED DAMAGE OCCURRED SUBSEQUENT TO DEVICE PACKAGING BEING OPENED. IN ADDITION, BECAUSE EXPECTED USE OF THIS DEVICE COMBINED WITH OBSERVED DAMAGED WOULD HAVE RESULTED IN SPONTANEOUS FLUID LOSS, QA CONCLUDED THAT DAMAGE MOST LIKELY OCCURRED DURING OR SUBSEQUENT TO EXPLANT.

    Description of Event or Problem · 1

    PER THE INFO PROVIDED BY THE PHYSICIAN'S OFFICE, THE DEVICE WAS REMOVED BECAUSE IT WAS "NOT FUNCTIONING AS INTENDED." AS REPORTED TO US, THE RESERVOIR WAS LEFT IN PLACE, WHILE THE REST OF THE DEVICE WAS REMOVED AND REPLACED.

    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 E90158/E90172

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention