BEUDAMED
    FDA Adverse Event Other Summary report: N

    S&W

    MDR report key: 1396500 · Received May 28, 2009

    Report

    Report Number
    8020045-2009-00005
    Event Type
    Other
    Date Received
    May 28, 2009
    Report Date
    May 6, 2009
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    DRX
    PMA / PMN Number
    K024264
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NEITHER A LOT NUMBER NOR SAMPLES HAVE BEEN MADE AVAILABLE TO US, NO ANALYSIS COULD BE PERFORMED SO FAR. WE HAVE ASKED OUR DISTRIBUTOR TO HAVE A DERMATOLOGIST TO EXAMINE THE DISCOLORATIONS. WE WILL PROVIDE A FOLLOW-UP REPORT AS SOON AS WE RECEIVE ADDITIONAL INFO.

    Description of Event or Problem · 1

    ON (B)(6), WE HAVE BEEN INFORMED ABOUT AN INCIDENT, WHICH HAPPENED APPROX ON (B)(6). AT (B)(4) HOSPITAL, A FEMALE PT UNDERWENT AN ECG PROCEDURE. ECG ELECTRODES, MODEL S & W 754, WERE APPLIED AND WORN FOR 6 - 8 HOURS. SOME TIME AFTER THE PROCEDURE, THE PT REPORTED THAT SHE STILL HAD VISIBLE OUTLINES OF THE ELECTRODES, ONE ON THE LEFT SHOULDER, THE OTHER ON THE LEFT SIDE OF THE ABDOMEN. SHE STATED THAT SHE WAS NOT IN PAIN, THE MARKS WERE NOT BLISTERS BUT "SIMPLY FADED OUTLINE MARKS". WE WERE INFORMED ABOUT THIS ON (B)(6). INQUIRING, WE LEARNED THAT THERE WAS NO GLUE RESIDUE LEFT ON THE SKIN AND RECEIVED TWO PHOTOS OF THE MARKS. ON (B)(6), IT WAS AGREED THE PT WOULD DIRECTLY CONTACT OUR DISTRIBUTOR IF THE CONCERN WAS STILL AN ISSUE. ON (B)(6) WE HAVE BEEN INFORMED THAT THE MARKS WERE STILL VISIBLE. THEY "STARTED LOOKING LIKE A BURN WITHOUT IRRITATION", "THEY ARE STILL VISIBLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S&W ECG ELECTRODE DRX LEONHARD LANG GMBH FSTB4 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other