BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACEMAKER PACK

    MDR report key: 6497119 · Received April 13, 2017

    Report

    Report Number
    MW5069118
    Event Type
    Malfunction
    Date Received
    April 13, 2017
    Date of Event
    April 5, 2017
    Report Date
    April 13, 2017
    Manufacturer
    AVID MEDICAL
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CATH LAB FOUND LONG BLACK HAIR IN DIFFERENT CATH TRAYS SUPPLIED BY AVID. THE HAIR WAS FOUND IN BOTH A CARDIAC CATH PACK AND A PACEMAKER PACK. THE PACKS WERE NOT USED. CARDIAC CATH PACK CATALOG #: VMCL025-4 LOT # 1221276. PACEMAKER PACK CATALOG # VMCL027-02 LOT #: 1223857.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274262 PACEMAKER PACK PACEMAKER PACK DTB AVID MEDICAL 1223857
    274263 AVID CARDIAC CATH PACK AVID CARDIAC CATH PACK OES AVID MEDICAL 1221276

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other