BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAVILON NO STING BARRIER FILM 1ML

    MDR report key: 7145730 · Received December 22, 2017

    Report

    Report Number
    7145730
    Event Type
    Injury
    Date Received
    December 22, 2017
    Manufacturer
    3M
    Product Code
    KMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICAL THERAPY ASSISTANT (PTA) WAS AT THE HOME PROVIDING PT SERVICES TO THE PATIENT. THE PATIENT REQUIRES THE USE OF KINIESOTAPE AS PART OF THE TREATMENT PLAN. TO ENSURE LONG TERM APPLICATION AND PREVENT THE KINIESOTAPE FROM FALLING OFF THE PTRA APPLIES SKIN PREP PRIOR TO APPLICATION. AT THIS VISIT PRIOR TO KINIESOTAPE APPLICATION THE PTA OPENED THE SKIN PREP AND TOUCHED THE PATIENT AT WHICH TIME AN "ELECTRIC SHOCK" OCCURRED WHICH THEN IGNITED A FIRE AND THE PATIENT CAUGHT ON FIRE. THE PTA WAS ABLE TO PUT THE FIRE BUT THE PATIENT DID SUFFER INJURY AS A RESULT OF THE EVENT. THE INJURY INCLUDES: SECOND DEGREE BURN TO THE POSTERIOR RIGHT LE AT THE ANKLE REGION; 1ST DEGREE BURN ON THE RLE THE PATIENT ALSO HAS DAMAGE TO HIS HOME WITH BURN MARKS ON THE CARPET. PT DOES NOT SMOKE AND THERE WAS NO OXYGEN IN THE HOME. THERE WAS NO FIRE (CANDLES ETC.) IN THE HOME. WE DID REPORT THE PROBLEM TO 3M; PT IS NOW RECEIVING NURSING CARE FOR WOUND CARE IN THE HOME; THE 2ND DEGREE BURN IS BEING TREATED WITH SILVADENE CREAM. THERAPY DATES: (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924227 CAVILON NO STING BARRIER FILM 1ML CAVILON NO STING BARRIER FILM 1ML KMF 3M 2020-05 GA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening| R