BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS

    MDR report key: 3133979 · Received May 23, 2013

    Report

    Report Number
    9610667-2013-00119
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    November 4, 2008
    Report Date
    March 26, 2013
    Manufacturer
    TORNIER SAS
    Product Code
    KWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    POST OP, OTHER COMPLICATIONS, LOOSE ANCHOR USED IN SUBSCAP REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230041 AEQUALIS NONE KWS TORNIER SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention