BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRO-PADZ

    MDR report key: 25159716 · Received May 13, 2026

    Report

    Report Number
    1218058-2026-00066
    Event Type
    Injury
    Date Received
    May 13, 2026
    Date of Event
    March 10, 2026
    Report Date
    April 23, 2026
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    UDI-DI
    00847946016661
    PMA / PMN Number
    P160022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), A SPARK WAS EMITTED FROM THE PADS AND BURNS WERE FOUND ON THE PATIENT AFTER REMOVING THE ELECTRODE PADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516307 PRO-PADZ ELECTRODES MKJ BIO-DETEK INCORPORATED 8900-4006 3625C 00847946016661

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other