BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAYCO 2500-5

    MDR report key: 23989790 · Received January 7, 2026

    Report

    Report Number
    MW5181880
    Event Type
    Malfunction
    Date Received
    January 7, 2026
    Report Date
    January 5, 2026
    Manufacturer
    HUZHOU JUNDA INDUSTRY CO., LTD.
    Product Code
    DRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE WITH 2% LOCAL ANESTHESIA AND LOCAL SEDATION, WHEN PROCEEDING WITH THE INCISION EXTENSION OF MORE THAN 2.5 CM OF SOME CYSTS ON THE BACK OF THE PATIENT IN PRONE POSITION, THE CUTTER IGNITED THAT CAUSED FIRE TO THE CHLORHEXIDINE GAUZE WHICH HAD BEEN IN CLOSE PROXIMITY CAUSING A SERIOUS INCIDENT AT CHRYRHO3FANE; HOWEVER, IT QUICKLY GOES OUT. THE ENTIRE SYSTEM WAS CHECKED, FINDING NO FAULT IN THE SYSTEM (GROUNDING INSTALLED, PLATE INSTALLED, AND AT NO TIME HAS THE DEVICE GIVEN ANY ALARM SIGNS). THE PATIENT WAS VISUALLY CHECKED AND DOES NOT PRESENT ANY SKIN LESIONS. THE PATIENT DID NOT FELT ANY PAIN OR BURNING ANYWHERE IN THE BODY. THERE WAS NO PATIENT INJURY. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REFERENCE REPORT# MW5181881.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49383 BLAYCO 2500-5 ELECTRODE, ELECTROCARDIOGRAPH DRX HUZHOU JUNDA INDUSTRY CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown