BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUFUSER

    MDR report key: 1628399 · Received February 22, 2010

    Report

    Report Number
    1722139-2010-00013
    Event Type
    Injury
    Date Received
    February 22, 2010
    Date of Event
    May 24, 2006
    Report Date
    February 10, 2010
    Manufacturer
    WALKMED INFUSION, LLC.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) CANNOT CONFIRM THE BASIS OF THIS COMPLAINT. SIGNIFICANT TIME HAS PASSED BETWEEN THE EVENT AND THE ALLEGATION OF A PRODUCT DEFECT. NO PRODUCT IS AVAILABLE FOR INVESTIGATION. (B) (4) BELIEVES THAT ITS PRODUCTS DO NOT LEAD TO NARROWING OF THE JOINT SPACE AND/OR CHONDROLYSIS WHEN USED ACCORDING TO THE PRODUCT'S LABELING AND DIRECTIONS FOR USE.

    Description of Event or Problem · 1

    A MAUDE EVENT REPORT WAS RECEIVED BY MOOG MEDICAL. DESCRIPTION IN MAUDE EVENT REPORT: USE OF POSTOPERATIVE PAIN PUMP DESTROYED SHOULDER CARTILAGE. THE DEVICE IS NOT AVAILABLE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUFUSER MEB WALKMED INFUSION, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention