BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVER TOFFLEMIRE TYPE RE

    MDR report key: 6036495 · Received October 18, 2016

    Report

    Report Number
    2523190-2016-00168
    Event Type
    Injury
    Date Received
    October 18, 2016
    Report Date
    September 26, 2016
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    JEP
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON OCTOBER 12, 2016. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINTS HISTORY. RESULTS: EVALUATION OF RETURNED DEVICE; THERE WERE TEN TOFFLEMIRE RETAINERS RETURNED WITH NO UNUSUAL MARKINGS AND COMPLAINT STATING THAT THE DOCTOR CUT HIMSELF. UPON FURTHER INVESTIGATION IT IS FOUND THAT MOST DO HAVE SHARP EDGES ON THEM. DHR REVIEW; THERE IS NO APPLICABLE NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY COMPLAINTS HISTORY; COMPLAINT METRICS TRACKED, TRENDED, AND REVIEWED MONTHLY WITH MANAGEMENT. CONCLUSION: THE COMPLAINT REPORT IS CONFIRMED; THE ROOT CAUSE HAS BEEN DETERMINED TO BE A WORKMANSHIP OR MATERIAL DEFICIENCY. APPROPRIATE ACTION HAS BEEN IMPLEMENTED TO RECTIFY THIS MANUFACTURING DEFICIENCY.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS DEVICE DEFECTIVE CUTS DOCTORS HAND. ON 9/30/2016 DOCTOR REPORTS SHE WAS APPLYING A BAND TO A LOWER R BACK MOLAR WHEN SHE WAS CUT ON SHARP THREADS OF THE DEVICE. NO SPECIAL TREATMENT NECESSARY, NO INFECTION. NO HARM TO PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689106 UNIVER TOFFLEMIRE TYPE RE M51 - GENERAL DENTISTRY JEP INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1