BEUDAMED
    FDA Adverse Event Summary report: N

    MULTI-FUNCTION ELECTRODE - PADPRO

    MDR report key: 3570372 · Received January 13, 2014

    Report

    Report Number
    1320894-2014-00004
    Date Received
    January 13, 2014
    Date of Event
    December 12, 2013
    Report Date
    January 13, 2014
    Manufacturer
    CONMED CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K014209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PADPRO MFE, MULTI-FUNCTION ELECTRODE, IS INTENDED FOR USE DURING DEFIBRILLATION, CARDIOVERSION, PACING, AND ECG MONITORING APPLICATIONS. THIS PRODUCT IS A SINGLE USE, DISPOSABLE DEVICE. THE SUSPECT DEVICE, PADPRO MFES, ARE NOT BEING RETURNED TO CONMED CORPORATION FOR EVALUATION FOR THEY HAVE BEEN DISCARDED BY THE END-USER. A REVIEW OF THE MANUFACTURING DOCUMENTS FROM THE DHR/LHR, DEVICE HISTORY RECORD/LOT HISTORY RECORD, HAS NOT BEEN ACCOMPLISHED AS THE LOT NUMBER OF THE DEVICE HAS NOT BEEN MADE AVAILABLE. A TWO (2) YEAR REVIEW OF COMPLAINT HISTORY SHOWS ONE (1) OTHER INCIDENT, OTHER THAN THIS PATIENT, FOR THE ENTIRE PRODUCT FAMILY OF PADPRO MULTI-FUNCTION-ELECTRODES, FOR THIS FAILURE MODE OF MEDICALLY TREATED ALLERGIC REACTION. THE CUSTOMER COMPLAINT IS CONFIRMED BASED ON THE RESULTS OF THE PATCH TESTING CONDUCTED BY THE DERMATOLOGIST. THIS IS A TRUE SKIN SENSITIZATION (ALLERGIC REACTION) TO THE HYDROGEL OF THE DEVICE. THE PATIENT NOW HAS A STANDING ORDER FOR CLOBETASOL (OLUX) A TOPICAL DERMATOLOGY MEDICAL FOR HIS UTILIZATION WHEN HE GOES FOR CARDIAC TESTING. CONMED CORPORATION HAD PROVIDED THE TECHNICAL DATA SHEET FOR THE PADPRO MFE TO THE DERMATOLOGY OFFICE FOR IDENTIFICATION OF THE INGREDIENTS OF THE PADPRO DEVICE THAT THE PATIENT HAS SHOWN SKIN SENSITIZATION TOWARDS. THE CUSTOMER FEELS THE TECHNICAL DATA SHEET FOR THIS DEVICE (SPECIFICALLY THE GEL COMPONENT) IS VAGUE AND HAS REQUESTED ADDITIONAL INFORMATION. I HAVE CONTACTED KATECHO,INC., WHO IS THE PROPRIETARY OWNER OF THE GEL COMPONENT OF THIS DEVICE. KATECHO HAS PROVIDED ME WITH A CERTIFICATE OF COMPOSITION REGARDING THE HYDROGEL UTILIZED IN THIS DEVICE. WITH KATECHO'S PERMISSION, THE CERTIFICATE OF COMPOSITION FOR THE HYDROGEL HAS BEEN FORWARDED TO THE END-USER TO PROVIDE MORE SPECIFIC INFORMATION REGARDING THE COMPONENTS OF THE DEVICE'S HYDROGEL. THE COMPLAINT INVESTIGATION HAS NOT IDENTIFIED ANY MANUFACTURING DEFECTS; THEREFORE, CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME. CONMED CORPORATION IS CONSIDERING THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "THE PATIENT JUST HAD CARDIAC TESTING AGAIN AND REACTED AGAIN. CARDIOLOGIST IS SAYING THERE IS NOTHING ELSE THAT THEY CAN USE FOR HIM. NICOLE SHOWED THE PHYSICIAN THE INFORMATION THAT I PROVIDED HER AND HE WANTED TO SEE IF WE COULD GET MORE SPECIFIC DETAILS ABOUT THE GEL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32715 MULTI-FUNCTION ELECTRODE - PADPRO PADPRO-MFE MKJ CONMED CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other