BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 135673 · Received December 3, 1997

    Report

    Report Number
    MW1012562
    Event Type
    Malfunction
    Date Received
    December 3, 1997
    Date of Event
    November 14, 1997
    Report Date
    November 14, 1997
    Manufacturer
    VINYL TECHNOLOGY INC.
    Product Code
    LHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PNEUMATIC TROUSERS HAVE AN AIR LEAK WHERE FILL TUBE CONNECTS WITH THE BLADDER ON LEFT LEG. DEFECT WAS FOUND WHILE PERFORMING A FUNCTIONAL TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * TROUSERS, PNEUMATIC, ANTI-SHOCK LHX VINYL TECHNOLOGY INC. MAST 111A *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other