BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKINTACT

    MDR report key: 1672804 · Received April 29, 2010

    Report

    Report Number
    8020045-2010-00004
    Event Type
    Injury
    Date Received
    April 29, 2010
    Report Date
    April 22, 2010
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    GEI
    PMA / PMN Number
    K063161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NEITHER A LOT NUMBER, SAMPLES OR OTHER FURTHER INFO HAVE BEEN MADE AVAILABLE TO US DESPITE OF REPEATED REQUESTS, NO ANALYSIS COULD BE PERFORMED. HOWEVER, THE BURN CLEARLY WAS THE RESULT OF A USER ERROR AS THE USER DID NOT FOLLOW THE IFU AND DID RE-USE A SINGLE USE DEVICE. THE IFU STATES: "DO NOT RE-USE THE NEUTRAL ELECTRODE". IT IS IMPOSSIBLE TO JUDGE THE QUALITY OF A DISPERSIVE ELECTRODE AFTER ITS USE. IF RE-USED ELECTRICAL AND/OR ADHESIVE PROPERTIES MIGHT BE INSUFFICIENT.

    Description of Event or Problem · 1

    ON 03/26, WE HAVE BEEN INFORMED ABOUT AN INJURY OF A PT AT (B) (6) HOSPITAL, (B) (6). THE DATE AND NATURE OF THE SURGERY IS STILL UNK TO US. A NON-MONITORING DISPERSIVE ELECTRODE (MODEL RO01B30) AND A ELECTROSURGICAL GENERATOR (NO MODEL HAS BEEN REVEALED) WERE USED. IT WAS REPORTED TO US THAT A FEMALE PT WAS BURNT DURING THE FIRST RE-USE OF THE DISPERSIVE ELECTRODE. TWO PHOTOS OF THE BURN WERE PROVIDED. HOWEVER, IT IS NOT POSSIBLE TO ESTIMATE LOCATION AND SIZE OF THE BURNS. NO INFO OF THE SIZE AND THE DEGREE OF THE BURN, HOW IT WAS TREATED AFTERWARDS, HOW THE SKIN WAS PREPARED, THE ORIENTATION OF THE ELECTRODE, THE LOT NUMBER OF THE ELECTRODE, THE GENERATOR MODEL, THE POWER SETTING USED COULD BE OBTAINED SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKINTACT ELECTROSURGICAL GROUNDING PLATE GEI LEONHARD LANG GMBH RO01B30 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other