BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR CORP

    MDR report key: 371933 · Received January 11, 2002

    Report

    Report Number
    MW1023833
    Event Type
    Malfunction
    Date Received
    January 11, 2002
    Date of Event
    January 3, 2002
    Report Date
    January 11, 2002
    Manufacturer
    MENTOR CORP
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FAILED PUMP ON PENILE IMPLANT. REQUIRED REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR CORP ALPHAL SCROTAL CYLINDER SET/PUMP;BIOFLEX RESERVOIR LOCKOUT V FHW MENTOR CORP ALPHAL SCROTAL CYLINDER SET/PUMP *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other ASSEMBLY KIT.| TRUE-LOC CONNECTORS REF#9480S LOT#778894.| BIOFLEX RESERVOIR LOCK OUT VALVE REF#9100K-LO,