BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANCE HD ROLLATOR

    MDR report key: 1513340 · Received October 12, 2009

    Report

    Report Number
    1056127-2009-00017
    Event Type
    Malfunction
    Date Received
    October 12, 2009
    Manufacturer
    ESSENTIAL MEDICAL SUPPLY, INC.
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL: EVALUATION RESULTS AND CONCLUSION: PLASTIC FORK ON LEFT SIDE OF UNIT HAS FRACTURED FROM THE POINT WHERE THE BEARING ASSEMBLY IS HOUSED. THIS FORK WILL BE SAVED FOR QAM. THE UNIT WAS SCRAPPED. INVESTIGATION RESULTS: FINAL DISPOSITION: THE FORK BROKE AROUND THE COLLAR. THE STUD AND BEARINGS WERE COMPLETELY IN TACT. A CAPA WAS OPENED (B)(4) 2009 TO ADDRESS THE DURABILITY OF FORK MATERIAL. PRELIMINARY TEST REPORTS SHOW THAT THE MATERIAL MET SPECS. ADDITIONAL INVESTIGATOR COMMENTS: THE DEALER STATES THAT PATIENT TOLD HER THAT HE NOTICED A HAIRLINE CRACK IN THE FORK AFTER HE FIRST RECEIVED UNIT, BUT DID NOT REPORT IT, OR RETURN THE UNIT. HE SAW THAT THE FORK WAS BREAKING THROUGH BUT THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS DISCOVERY. DEALER TOLD HIM THAT ALL SUCH PROBLEMS SHOULD BE REPORTED. IT IS MORE THAN POSSIBLE THAT THE UNIT WAS INITIALLY DAMAGED DURING SHIPMENT AND THIS WAS NOTICED BY THE PATIENT ONLY AFTER FIRST USE. FAILURE TO REPORT PROBLEM IS CONTRADICTORY TO INSTRUCTIONS IN USER MANUAL.

    Description of Event or Problem · 1

    PATIENT RETURNED UNIT TO DEALER WITH BROKEN PLASTIC FORK. PATIENT HAD NOTICED HAIRLINE CRACK IN FORK WHEN HE FIRST RECEIVED IT, BUT DID NOT REPORT IT, OR RETURN WALKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANCE HD ROLLATOR ROLLATOR ITJ ESSENTIAL MEDICAL SUPPLY, INC. W1801

    Patients

    Seq Age Sex Outcome Treatment
    1