BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPONSE RESUSCITATOR, ADULT

    MDR report key: 986137 · Received May 5, 2006

    Report

    Report Number
    1217052-2006-00032
    Event Type
    Malfunction
    Date Received
    May 5, 2006
    Report Date
    April 24, 2006
    Manufacturer
    GALEMED CORPORATION
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE HAS A WHITE REINFORCEMENT RING ON THE FACE MASK AND THE USER FACILITY ALLEGES THAT THEIR SAMPLE DID NOT HAVE THE WHITE COLLAR FOR THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPONSE RESUSCITATOR, ADULT * BTM GALEMED CORPORATION NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 *