BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSUTURE

    MDR report key: 276054 · Received April 28, 2000

    Report

    Report Number
    MW1018786
    Event Type
    Malfunction
    Date Received
    April 28, 2000
    Date of Event
    April 27, 2000
    Report Date
    April 27, 2000
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    FHO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE BALLOON DID NOT INFLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSUTURE INFLATION BULB FHO UNITED STATES SURGICAL CORP. OMST10SB 203219

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other