BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E9000 BUR LSO, ROUND 4 X 30MM

    MDR report key: 792105 · Received December 7, 2006

    Report

    Report Number
    1017294-2006-00569
    Event Type
    Malfunction
    Date Received
    December 7, 2006
    Date of Event
    October 13, 2006
    Report Date
    October 13, 2006
    Manufacturer
    CONMED LINVATEC
    Product Code
    GET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING AN INTERNAL STOCK AUDIT, IT WAS NOTED THAT THE POUCH USED TO PACKAGE THE BUR HAD A FOLDOVER IN THE SEAL, RESULTING IN A BREACH IN THE STERILITY OF THE PRODUCT.

    Description of Event or Problem · 1

    A POTENTIAL FOR COMPROMISE IN THE STERILITY OF THE PRODUCT WAS NOTED DURING AN INTERNAL STOCK AUDIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E9000 BUR LSO, ROUND 4 X 30MM BUR GET CONMED LINVATEC NA BBC66134

    Patients

    Seq Age Sex Outcome Treatment
    1 NA