BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEDSTROEM M-ACCESS 21MM 015

    MDR report key: 19220771 · Received May 1, 2024

    Report

    Report Number
    8031010-2024-00050
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    March 18, 2024
    Report Date
    May 14, 2024
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EKS
    UDI-DI
    J003A16MA021015121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED THAT THERE WAS A SMALL AMOUNT OF BLEEDING AT THE TIME AND IT WAS RESOLVED SOON. NO FURTHER TREATMENT IS REQUIRED. INVESTIGATION SUMMARY: INVOLVED PRODUCT THAT DIDN'T GIVE SATISFACTION WAS NOT RETURNED AND CANNOT BE ANALYZED. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1852692). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. PLEASE NOTE FOR INFORMATION THAT HEDSTROEM FILES M-ACCESS 21MM 015 HAVE A POINTED TIP. IN CONSEQUENCE, THESE INSTRUMENTS MUST BE HANDLED WITH CARE BEFORE CANAL PREPARATION TO AVOID ANY PATIENT INJURY.

    Additional Manufacturer Narrative · 0

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, IF THIS MALFUNCTION RECURRED, IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LOT NUMBER WAS PROVIDED AND RETAINED-PRODUCT TESTING AND/OR DHR REVIEW ARE PLANNED. THE RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT HEDSTROEM M-ACCESS 21MM 015 THAT WAS USED IN TREATMENT OF A PATIENT, PUNCTURED THE PATIENT IN THE MOUTH WHICH LED TO BLEEDING GUMS. TREATMENT WAS COMPLETED AND PATIENT HAD NO DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2081317 HEDSTROEM M-ACCESS 21MM 015 FILE, PULP CANAL, ENDODONTIC EKS MAILLEFER INSTRUMENTS HOLDING SARL 1852692 J003A16MA021015121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown