BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROUNDING PAD

    MDR report key: 7915524 · Received September 27, 2018

    Report

    Report Number
    1060680-2018-00006
    Event Type
    Malfunction
    Date Received
    September 27, 2018
    Date of Event
    August 29, 2018
    Report Date
    October 11, 2018
    Manufacturer
    MODERN MEDICAL EQUIPMENT MANUFACTURING LTD.
    Product Code
    GEI
    UDI-DI
    00749756142014
    PMA / PMN Number
    K984276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE: BECAUSE THE GROUNDING PAD IS SUPPLIED TO DEROYAL BY MODERN MEDICAL, A SUPPLIER CORRECTIVE ACTION REQUEST WAS ISSUED TO MODERN MEDICAL FOR ASSISTANCE IN DETERMINING A ROOT CAUSE. TESTING OF RETAINED SAMPLES BY THE MANUFACTURER FOUND THAT THE STICKINESS OF THE HYDROGEL WAS WITHIN SPECIFICATION. A ROOT CAUSE FOR THE REPORTED FAILURE COULD NOT BE DETERMINED. CORRECTIVE ACTION: DUE TO THE ROOT CAUSE DETERMINATION, A CORRECTIVE ACTION HAS NOT BEEN TAKEN. INVESTIGATION SUMMARY AN INTERNAL COMPLAINT (CALL 45066) WAS RECEIVED INDICATING THAT THE HYDROGEL ON A GROUNDING PAD (PART NUMBER 88-000202, LOT 170606011) HAD DRIED UP, AND THEREFORE, THE PAD WAS NOT STICKING TO THE PATIENT PROPERLY. THIS REPORTEDLY RESULTED IN THE PATIENT SUSTAINING BURNS. THE DEFECTIVE ITEM WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT INVESTIGATOR REVIEWED THE PURCHASE ORDER FOR POSSIBLE DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DISCREPANCIES WERE DOCUMENTED. THE GROUNDING PAD IS SUPPLIED TO DEROYAL BY MODERN MEDICAL EQUIPMENT. THE 2015-2017 SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) AND SUPPLIER NOTIFICATION LETTER LOGS WERE REVIEWED FOR SIMILAR COMPLAINTS. SIMILAR COMPLAINTS WERE IDENTIFIED. THEREFORE, A SCAR WAS ISSUED TO MODERN MEDICAL. A RESPONSE WAS RECEIVED AND ACCEPTED BY DEROYAL'S COMPLAINT INVESTIGATOR. IN ITS SCAR RESPONSE, MODERN MEDICAL STATED PRODUCTION RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, RETAINED SAMPLES WERE TESTED FOR GEL STICKINESS. ALL SAMPLES TESTED WERE WITHIN SPECIFICATION. DEROYAL HAS SOLD 2,093 CASES OF THE FINISHED GOOD BETWEEN DECEMBER 17, 2016 AND AUGUST 17, 2018. EACH CASE CONTAINS 50 EACH, WHICH EQUATES TO A TOTAL OF 104,650 EACHES SOLD. ONLY TWO COMPLAINTS WITH THE REPORTED ISSUE WERE IDENTIFIED, WHICH RESULTS IN A COMPLAINT-TO-SALES RATIO OF 0.001911132 PERCENT. DEROYAL WILL CONTINUE TO MONITOR POST MARKET FEEDBACK AND WILL RECOGNIZE IN THE FUTURE IF THE ISSUE REOCCURS. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    THE HYDROGEL ON THE GROUNDING PADS WAS DRIED UP. THE PADS DID NOT STICK TO THE PATIENT PROPERLY, AND IN ONE INCIDENT, THIS CAUSED BURNS TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (CALL (B)(4)) WAS RECEIVED INDICATING THAT THE HYDROGEL ON A GROUNDING PAD (PART NUMBER 88-000202, LOT 170606011) HAD DRIED UP, AND THEREFORE, THE PAD WAS NOT STICKING TO THE PATIENT PROPERLY. THIS REPORTEDLY RESULTED IN THE PATIENT SUSTAINING BURNS. THE DEFECTIVE ITEM WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT INVESTIGATOR REVIEWED THE PURCHASE ORDER FOR POSSIBLE DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DISCREPANCIES WERE DOCUMENTED. THE GROUNDING PAD IS SUPPLIED TO DEROYAL BY (B)(4). THE 2015-2017 SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) AND SUPPLIER NOTIFICATION LETTER LOGS WERE REVIEWED FOR SIMILAR COMPLAINTS. SIMILAR COMPLAINTS WERE IDENTIFIED. THEREFORE, A SCAR WAS ISSUED TO MODERN MEDICAL. AS OF THE DATE OF THIS REPORT, A RESPONSE HAS NOT BEEN RECEIVED. DEROYAL HAS SOLD (B)(4). DEROYAL WILL CONTINUE TO MONITOR POST MARKET FEEDBACK AND WILL RECOGNIZE IN THE FUTURE IF THE ISSUE REOCCURS. THE INVESTIGATION IS ONGOING AT THIS TIME. IF NEW AND ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE HYDROGEL ON THE GROUNDING PADS WAS DRIED UP. THE PADS DID NOT STICK TO THE PATIENT PROPERLY, AND IN ONE INCIDENT, THIS CAUSED BURNS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756311 GROUNDING PAD ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MODERN MEDICAL EQUIPMENT MANUFACTURING LTD. 88-000202 170606011 00749756142014

    Patients

    Seq Age Sex Outcome Treatment
    1