BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVORY CLAMP

    MDR report key: 2629817 · Received June 20, 2012

    Report

    Report Number
    1925223-2012-00045
    Event Type
    Malfunction
    Date Received
    June 20, 2012
    Date of Event
    May 23, 2012
    Report Date
    May 25, 2012
    Manufacturer
    HERAEUS KULZER LLC
    Product Code
    EJG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE CLAMP BREAKAGE ALLEGEDLY OCCURRING ON FAIRLY NEW THE CLAMP THE MALFUNCTION WILL BE REPORTED TO MAINTAIN COMPLIANCE WITH 21 CFR 803 AND OUT OF AN ABUNDANCE OF CAUTION. CONCLUSION: DEVICE BREAKAGE IS ADDRESSED IN THE DIRECTIONS FOR USE. THE DIRECTIONS STATE, "CAUTION: MODIFICATION, OVEREXTENDING, BENDING OR EXTENDED USE OF THE CLAMP MAY CAUSE BREAKAGE." THE DENTIST HAS STATED THAT NO ONE WAS INJURED DURING THE INCIDENCES.

    Description of Event or Problem · 1

    ON (B)(6) 2012, HENRY SCHEIN REP SENT (B)(4). THE DESCRIPTION ON THE FORM WAS, "CLAMP BROKE IN PT'S MOUTH WITH NO INJURY." ON (B)(4) 2012, I SPOKE TO THE ASSISTANT. I ASKED WHEN THIS OCCURRED. SHE SAID IT WAS ON FRIDAY ((B)(6) 2012). SHE SAID THE PT WAS (B)(6) MALE. THEY WERE REMOVING THE CLAMP FROM A LOWER MOLAR, SHE DID NOT REMEMBER WHICH ONE, AND IT BROKE. SHE SAID THAT THE RUBBER DAM WAS IN PLACE AND THE CLAMP PIECES FELL TO THE FLOOR. I ASKED HER IF SHE KNEW HOW MANY USES WERE ON THE CLAMP. SHE SAID SHE WAS NOT SURE, BUT THAT THE CLAMP WAS FAIRLY NEW. I ASKED IF ANYONE WAS INJURED. SHE SAID THAT NO ONE WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVORY CLAMP CLAMP, RUBBER DAM EJG HERAEUS KULZER LLC SS 12A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR