BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEL FACE MASK

    MDR report key: 2922382 · Received January 18, 2013

    Report

    Report Number
    1643264-2013-00002
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 21, 2012
    Manufacturer
    SMITH & NEPHEW OKLAHOMA CITY MANUFACTURING SITE
    Product Code
    BZD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    TWO DAYS AFTER A SURGERY, DERMABRASIONS WERE FOUND AT FRONT AND BACK OF THE PATIENT'S HEAD. THE DURATION OF THE SURGERY WAS ABOUT 4 HOURS. DURING THE SURGERY, THE FOREHEAD AND CHIN OF THE PATIENT WERE PROTECTED BY COATING. ACCORDING TO ONE OF THE STAFFS AT THE FACILITY, SHE/HE FELT THAT THE DOCTOR FASTENED THE STRAP OF THE DEVICE TOO TIGHT. BEFORE USE, THE DEVICE WAS WASHED BY USING A NEUTRAL DETERGENT. SINCE THERE WAS NO DAMAGE ON THE DEVICE, IT WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27442 GEL FACE MASK GEL FACE MASK BZD SMITH & NEPHEW OKLAHOMA CITY MANUFACTURING SITE

    Patients

    Seq Age Sex Outcome Treatment
    1