BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLYTE TOGA, PEELAWAY,2X

    MDR report key: 3292277 · Received August 16, 2013

    Report

    Report Number
    0001811755-2013-01961
    Event Type
    Malfunction
    Date Received
    August 16, 2013
    Date of Event
    July 29, 2013
    Report Date
    July 29, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FYA
    PMA / PMN Number
    K073017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; IT WAS DISPOSED OF BY THE USER FACILITY. IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT WITHOUT AN EVALUATION OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE SEAM OF THE TOGA TORE SIGNIFICANTLY ON THE BACK OF THE ARM. IT WAS REPORTED THAT THE TEAR WAS COVERED WITH ADHESIVE DRAPE AND THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397030 FLYTE TOGA, PEELAWAY,2X GOWN, SURGICAL FYA STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1