BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRO-PADZ

    MDR report key: 25161957 · Received May 13, 2026

    Report

    Report Number
    1218058-2026-00067
    Event Type
    Injury
    Date Received
    May 13, 2026
    Date of Event
    April 22, 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
    FL, 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 DEFIBRILLATING A PATIENT (AGE AND GENDER UNKNOWN), SPARKS WERE EMITTED FROM THE PADS DURING DISCHARGE AND AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUSTAINED STERNAL BURNS. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27800 PRO-PADZ ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-4006 0926B 00847946016661

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other