BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER 400 ML HEMOVAC INFECTION CONTROL

    MDR report key: 1050339 · Received May 23, 2008

    Report

    Report Number
    1526350-2008-00026
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    October 31, 2007
    Report Date
    April 25, 2008
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
    Product Code
    GCY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PROD IS CURRENTLY UNDER RECALL. CUSTOMER REPORTED INCIDENT IN RESPONSE TO RECALL LETTER NOTIFICATION. DEVICE WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    PRACTITIONER PLACED HEMOVAC DURING RIGHT KNEE ARTHROSCOPY. HEMOVAC REMOVED THE SAME DATE. PT DEVELOPED POST-OP INFECTION OF RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER 400 ML HEMOVAC INFECTION CONTROL WOUND DRAINAGE DEVICE GCY ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1