BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVORY CLAMP

    MDR report key: 3901575 · Received June 30, 2014

    Report

    Report Number
    1925223-2014-00053
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Report Date
    June 2, 2014
    Manufacturer
    HERAEUS KULZER LLC
    Product Code
    EEF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. RESULTS: DEVICE PROBLEMS CAUSED BY THE SEPARATION OF A COMPONENT, OBJECT, OR MATERIAL INTO TWO OR MORE PIECES INCLUDING SHEAR. CONCLUSION: ACTUAL DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    THIS CLAMP BREAKAGE OCCURRED IN (B)(6). (B)(6) FROM SIGMA DENTAL (B)(6) EMAILED THE FOLLOWING: CUSTOMER RETURNED 2 IVORY CLAMPS SS 2 DUE TO THE FACT THAT THEY ARE BROKEN. THE CORRESPONDING SERIAL NUMBER IS (B)(4). BOTH CLAMPS HAVE BEEN PURCHASED BY THE CUSTOMER ON (B)(6) 2014. NO INCIDENT DATE(S) WERE PROVIDED. THE MALFUNCTION WILL BE REPORTED TO MAINTAIN COMPLIANCE WITH 21 CFR 803 AND OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379601 IVORY CLAMP CLAMP, RUBBER DAM EEF HERAEUS KULZER LLC SS 2

    Patients

    Seq Age Sex Outcome Treatment
    1