BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOVAC KIT

    MDR report key: 541340 · Received August 31, 2004

    Report

    Report Number
    1526350-2004-00016
    Event Type
    Injury
    Date Received
    August 31, 2004
    Date of Event
    May 27, 2004
    Report Date
    July 19, 2004
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
    Product Code
    ILZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2004 DR ATTEMPTED TO REMOVE A 1/8" HEMOVAC DRAIN, MODEL NUMBER 00-2550-002-10 FROM A PT POSTOPERATIVELY ON THE FLOOR. THE ATTEMPT FAILED WHEN THE DRAIN ALLEGEDLY BROKE. THE PHYSICIAN CUT OFF AND DISCARDED THE TORN END OF THE DRAIN PRIOR TO BRINGING THE PT BACK TO THE OR FOR SURGICAL REMOVAL OF THE REMAINING PORTION OF THE DRAIN. THE REMAINDER OF THE DRAIN WAS SUCCESSFULLY REMOVED AND WAS SENT TO PATHOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOVAC KIT WOUND DRAINAGE DEVICE ILZ ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS * NI

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention