BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKINTACT

    MDR report key: 5038437 · Received August 25, 2015

    Report

    Report Number
    8020045-2015-00055
    Event Type
    Injury
    Date Received
    August 25, 2015
    Report Date
    August 25, 2015
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    DRX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO LOT NUMBER WAS PROVIDED, NO TESTS COULD BE PERFORMED ON RETAINED SAMPLES. AFTER SEVERAL REQUESTS FOR FURTHER INFORMATION WE WERE NOT ABLE TO OBTAIN ANY. OUR DISTRIBUTOR INFORMED US: "WE HAVE NOT BEEN ABLE TO OBTAIN ANY PHOTOGRAPHS OR SAMPLES REGARDING THIS INCIDENT. WE HAVE SUPPLIED THE LIST OF INGREDIENTS OF THE GEL OF FTBI AS REQUESTED. THEREFORE WE CONSIDER THIS COMPLAINT CLOSED." NO FURTHER CONCLUSION CAN BE DRAWN WHAT HAS CAUSED THE DISTINCT DARK MARK OF THE PATIENT AND IF THIS DISTINCT DARK MARK CONSTITUTES A REPORTABLE INJURY.

    Additional Manufacturer Narrative · 1

    AS NO LOT NUMBER WAS PROVIDED, NO TESTS COLD BE PERFORMED ON RETAINED SAMPLES. DUE TO THE LACK OF INFO, WE ARE UNABLE TO ESTABLISH, IF THESE DISTINCT DARK MARK CONSTITUTES A REPORTABLE INJURY. WE WILL TRY TO OBTAIN ADD'L INFO AND WILL PROVIDE A FOLLOW UP REPORT, WHEN WE RECEIVE IT.

    Description of Event or Problem · 1

    ON (B)(6) 2015, WE HAVE BEEN INFORMED ABOUT AN INCIDENT W/ECG ELECTRODES. SHORT TERM WAS PLACED ON THE LEFT THIGH. IT WAS REPORTED THT NO HAIR WAS UNDERNEATH THE ELECTRODES (UNKNOWN MODEL) WERE USED. NO LOT NUMBER WAS PROVIDED. THE COMPLAINANT REPORTED, "THE PATIENT HAS REPORTED A DISTINCT DARK MARK ON HER SKIN WHERE THE ELECTRODES HAD BEEN PLACED AND THIS HAS NOT GONE AWAY DESPITE THE ELECTRODES BEING REMOVED JUST OVER A MONTH AGO. THE ELECTRODES WERE IN SITU FOR APPROXIMATELY 16 HOURS AND THE PATIENT DOES NOT REPORT ANY KNOWN ALLERGIES OR SKIN LESIONS." NO FURTHER INFO WAS PROVIDED DESPITE REPEATED REQUESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560171 SKINTACT ECG ELECTRODE DRX LEONHARD LANG GMBH UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other