BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLEARTRACE;50;TP;ADGEL (1000/CS)

    MDR report key: 10818154 · Received November 10, 2020

    Report

    Report Number
    1320894-2020-00476
    Event Type
    Death
    Date Received
    November 10, 2020
    Date of Event
    July 29, 2020
    Report Date
    December 11, 2020
    Manufacturer
    CONMED CORPORATION
    Product Code
    DRX
    PMA / PMN Number
    K091856
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE 1700-050 IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. THIS COMPLAINT OF INGESTED DEVICE IS UNABLE TO BE VERIFIED AND A ROOT CAUSE CANNOT BE DETERMINED. A DHR REVIEW CANNOT NOT BE CONDUCTED DUE TO THE UNAVAILABILITY OF THE LOT/SERIAL NUMBER. A TWO-YEAR LOT HISTORY REVIEW CANNOT BE CONDUCTED AS NO LOT NUMBER WAS PROVIDED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 2 COMPLAINTS, (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: PRODUCT DESCRIPTION: GENERAL PURPOSE MONITORING ELECTRODES MAY TYPICALLY BE USED FOR UP TO 5 DAYS. RESTING ECG ELECTRODES ARE TYPICALLY USED FOR SHORT TERM (30 MINUTES) APPLICATIONS. DURATION OF USE MAY VARY AND DEPENDING UPON SKIN CONDITION AND ENVIRONMENTAL FACTORS. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 1700-050 DEVICE WAS BEING USED FOR ELECTROCARDIOGRAM MONITOR OF A PATIENT WHEN SHE WAS HOSPITALIZED ON (B)(6) 2020. THE MONITORING WAS STOPPED ON (B)(6) 2020 AND THE DEVICE WAS REPORTEDLY REMOVED FROM THE PATIENT. HOWEVER, IT WAS THEN REPORTED THAT THE PATIENT HAD SWALLOWED A DEVICE DUE TO A GASTROSCOPE THAT WAS PERFORMED ON (B)(6) 2020 DUE TO OBSERVATION OF ANEMIA AND GASTROINTESTINAL BLEEDING. UNRELATED TO THE DEVICE DIGESTION OF THE ELECTRODE THE PATIENT WAS THEN REPORTED AS HAVING DIED. THIS WAS REPORTED TO CONMED BY THE DISTRIBUTOR ON 26OCT2020. THE HOSPITAL HAD REPORTED TO THE DISTRIBUTOR THAT THERE WAS NO INJURY DUE TO THE DEVICE INGESTION. THE HOSPITAL REPORTED THAT THE PATIENT HAD A HISTORY OF HERNIA AND WAS AFFECTED BY ESOPHAGEAL REFLUX DISEASE GRADE D. THIS REPORT IS BEING RAISED ON THE BASIS OF DEVICE BEING USED ON PATIENT AND THEN PATIENT DEATH OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285553 CLEARTRACE;50;TP;ADGEL (1000/CS) ELECTRODE, ELECTROCARDIOGRAPH DRX CONMED CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| O