BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEAT BANDS

    MDR report key: 4192508 · Received October 22, 2014

    Report

    Report Number
    0001811755-2014-03704
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 24, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    LYU
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS NOT DUPLICATED AND NO ADDITIONAL FAILURES WERE CONFIRMED. THE DEVICE WAS TESTED FOR CONTAMINATION AND IT WAS CONFIRMED THAT NO TRACE RESIDUES WERE PRESENT THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETED. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE CONDUCTED AT THE USER FACILITY, THE USER HAD A DERMAL ALLERGIC REACTION LOCALIZED TO THE AREA WHERE THE DEVICE TOUCHED THE USER¿S HEAD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY. THE USER SOUGHT MEDICAL ADVICE FOR THE ALLERGIC REACTION; HOWEVER, THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING ANY TREATMENT AND/OR MEDICATION ADMINISTERED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE CONDUCTED AT THE USER FACILITY THE USER HAD A DERMAL ALLERGIC REACTION LOCALIZED TO THE AREA WHERE THE DEVICE TOUCHED THE USER¿S HEAD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY. THE USER SOUGHT MEDICAL ADVICE FOR THE ALLERGIC REACTION; HOWEVER, THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING ANY TREATMENT AND/OR MEDICATION ADMINISTERED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671589 SWEAT BANDS ACCESSORY, SURGICAL APPAREL LYU STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other