BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROUNDING PAD WITH ADHESIVE GEL

    MDR report key: 5633679 · Received May 5, 2016

    Report

    Report Number
    1060680-2016-00006
    Event Type
    Malfunction
    Date Received
    May 5, 2016
    Date of Event
    April 5, 2016
    Report Date
    May 5, 2016
    Manufacturer
    MODERN MEDICAL EQUIPMENT MANUFACTURING LTD.
    Product Code
    GEI
    PMA / PMN Number
    K984276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THE TRUE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED. IT IS UNKNOWN WHETHER THERE IS A POTENTIAL PATIENT SENSITIVITY OR THE MANNER IN WHICH THE DEVICE WAS REMOVED. CORRECTIVE ACTION: DUE TO THE INVESTIGATION AND ROOT CAUSE DETERMINATION, A CORRECTIVE ACTION HAS NOT BEEN TAKEN. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED INDICATING THAT A GROUNDING PAD ((B)(4)) LEFT A MARK ON A PATIENT. ADDITIONAL INFORMATION WAS RETRIEVED 4/13/2016 FROM THE END USER REGARDING THE NATURE OF THE MARK LEFT ON THE PATIENT. IT WAS STATED THE PROCEDURE LAST FIVE HOURS. NO FLUIDS WERE UTILIZED AS PART OF THE PREP AND APPLICATION OF THE DEVICE AND NO DIRECT CONTACT WAS MADE WITH THE WARMING BLANKET. THE MARK WAS IDENTIFIED AS NOT BEING A BURN BUT A TYPE OF REACTION. IT WAS RED WITH AN INDENTATION AND CLEARLY INDICATED WHERE THE ADHESIVE WAS PRESENT. ACCORDING TO THE END USER, THE MARK WENT AWAY WITHIN A DAY. THE SAMPLE WAS RETURNED TO DEROYAL FOR EVALUATION. (B)(4), LOT NUMBER 151106005, IS SUPPLIED TO DEROYAL BY (B)(4) HAS PROVIDED EVIDENCE THE PRODUCT WAS SUBJECTED TO CYTOXICITY, IRRITATION, AND SENSITIZATION BIOCOMPATIBILITY TESTING. THE PRODUCT FAILURE MODE, EFFECTS AND CRITICALITY ANALYSIS WAS REVIEWED FOR POTENTIAL FAILURE MODES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE FOLLOWING THREE FAILURE MODES WERE IDENTIFIED: ALLERGIC REACTION TO THE PAD COMPONENTS, CONTACT DERMATITIS DUE TO UNKNOWN PATIENT SENSITIVITY, AND SKIN TRAUMA DUE TO USER ERROR OF REMOVING THE DEVICE TOO RAPIDLY. DEROYAL PROVIDES AN INSTRUCTIONS FOR USE WITH THE CASE OF PRODUCT PRIOR. STEP 8 UNDER DIRECTIONS FOR USE STATES, "AFTER THE PROCEDURE AND WHEN REMOVING THE ELECTRODE GENTLY SUPPORT THE SKIN AND SLOWLY PEEL AWAY THE ELECTRODE. RAPID REMOVAL MAY CAUSE SKIN TRAUMA, SKIN INJURY, OR IRRITATION. DO NOT PULL ON THE CABLE OR THE CORD." (B)(4). DEROYAL WILL CONTINUE TO MONITOR TRENDS FOR THIS FAILURE AND WILL RECOGNIZE IN THE FUTURE IF IT TRANSITIONS FROM AN ISOLATED EVENT INTO A RECURRING ISSUE. PREVENTIVE ACTION: DUE TO THE INVESTIGATION AND ROOT CAUSE DETERMINATION, A PREVENTIVE ACTION IS NOT BEING TAKEN. THE INVESTIGATION IS COMPLETE. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE GROUNDING PAD LEFT A RED MARK WITH INDENTATION ON THE PATIENT. IT TOOK A DAY FOR THE MARK TO GO AWAY. THE HOSPITAL REPORTED IT WAS CLEAR AS TO WHERE THE ADHESIVE ON THE PAD WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290784 GROUNDING PAD WITH ADHESIVE GEL ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MODERN MEDICAL EQUIPMENT MANUFACTURING LTD. 151106005

    Patients

    Seq Age Sex Outcome Treatment
    1