BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKINTACT

    MDR report key: 5025418 · Received August 21, 2015

    Report

    Report Number
    8020045-2015-00052
    Event Type
    Injury
    Date Received
    August 21, 2015
    Date of Event
    July 9, 2015
    Report Date
    August 20, 2015
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    DRX
    PMA / PMN Number
    K063161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETAINED SAMPLES OF THE INVOLVED LOT HAVE BEEN INSPECTED VISUALLY AND TESTED MECHANICALLY. THE MECHANICAL TESTS WERE PERFORMED ON 3 RETAINED SAMPLES. ALL SAMPLE WERE FOUND TO PERFORM WITHIN LIMITS. THE ADHESIVE PERFORMANCE WAS ALSO TESTED FOR 4 HOURS ON A TEST PERSON. NO FAULTS COULD BE DETECTED. BASED ON THE INFORMATION AVAILABLE NO CONCLUSION CAN BE DRAWN SO FAR. IT IS ALSO POSSIBLE THAT THE INCIDENT DOES NOT CONSTITUTE A REPORTABLE EVENT. WE WILL TRY TO OBTAIN ADDITIONAL INFORMATION AND WILL PROVIDE A FOLLOW UP REPORT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: WE HAVE REPEATEDLY REQUESTED TO GET ADDITIONAL INFORMATION AND THE INVOLVED SAMPLE. WE HAVE NOW BEEN INFORMED BY OUR DISTRIBUTOR THAT THEY HAVE CLOSED THE COMPLAINT AS NO FURTHER DETAILS HAVE BEEN MADE AVAILABLE TO THEM. WE, THEREFORE, CLOSE THE COMPLAINT FROM OUR SIDE.

    Description of Event or Problem · 1

    ON (B)(6) AN EXTENDED RIGHT HEPATECTOMY IN TH7 SURGERY WAS PERFORMED AT (B)(6). A MONITORING DISPERSIVE ELECTRODE (MODEL RSW25) AND A UNKNOWN GENERATOR WERE USED. THE DISPERSIVE ELECTRODE WAS PLACED ON THE LEFT THIGH. IT WAS REPORTED WHEN THE DISPERSIVE ELECTRODE WAS REMOVED FROM THE PATIENT SKIN PEELED OFF SUPERFICIALLY AND A SLIGHT REDNESS WAS NOTICED. THE INITIAL REPORT ALSO DISCLOSED THAT THE REDNESS SUBSIDED DURING THE NIGHT. NO INFORMATION ABOUT THE PATIENT, THE PATIENT'S MEDICAL HISTORY, THE PATIENT POSITION, HOW THE SKIN WAS PREPARED, THE ORIENTATION OF THE ELECTRODE, THE GENERATOR MODEL, THE POWER SETTINGS, THE POSITION AND SHAPE OF THE INJURY AND HOW THE INJURY WAS TREATED AFTERWARDS HAVE BEEN RECEIVED BY US DESPITE OF REPEATED REQUESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555650 SKINTACT ELECTROSURGICAL DISPERSIVE ELECTRODE DRX LEONHARD LANG GMBH RSW25 50602-0809

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other