BEUDAMED
    FDA Adverse Event Summary report: N

    3M ESPE PENTAMIX LITE AUTOMATIC MIXING UNIT

    MDR report key: 4254814 · Received November 11, 2014

    Report

    Report Number
    9611385-2014-00016
    Date Received
    November 11, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    3M DEUTSCHLAND GMBH
    Product Code
    EFD
    PMA / PMN Number
    K991913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD, RESULTS, CONCLUSIONS: UNFORTUNATELY THE SALES REPRESENTATIVE DID NOT COLLECT THE AFFECTED PRODUCTS AT ONCE AND THE PRODUCTS WEREN'T RETURNED TO 3M ESPE AND THE LOT-NOS ARE NOT KNOWN. THEREFORE NO FURTHER ANALYSIS ON THE PRODUCT OR RETAINED SAMPLE COULD BE DONE. THE IMPRESSION MATERIAL HAS BEEN ASSESSED FOR BIOCOMPATIBILITY AND HAS BEEN FOUND TO BE SAFE FOR ITS INTENDED USE. AS TWO PRODUCTS WERE INVOLVED IN THE ADVERSE EVENT, TWO RECORDS WILL BE SENT TO FDA. THIS REPORT (MANUFACTURER REPORT NUMBER: 9611385-2014-00016) DESCRIBES THE SECOND SUSPECT DEVICE. THE FIRST SUSPECT DEVICE DESCRIPTION IS INCLUDED IN MANUFACTURER REPORT NUMBER 9611385-2014-00015.

    Description of Event or Problem · 1

    ON (B)(6) 2014 A POTENTIAL ADVERSE EVENT OCCURRED THAT INVOLVED THE 3M ESPE PRODUCTS 3M ESPE PENTAMIX LITE AND 3M ESPE IMPRINT 4 PENTA SUPER QUICK. DURING OPERATION THE MIXING TIP OF THE PENTAMIX MIXING DEVICE CLOGGED AND DETACHED ABRUPTLY. THE IMPRESSION MATERIAL IMPRINT 4 PENTA SUPER QUICK WAS RELEASED UNDER PRESSURE AND THE DENTAL PERSONAL WAS BESPATTERED. NOBODY WAS INJURY. A SALES REPRESENTATIVE OF 3M (B)(4) WAS PRESENT AT THE DOCTOR'S OFFICE DURING THE INCIDENT AND REPORTED THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726437 3M ESPE PENTAMIX LITE AUTOMATIC MIXING UNIT AMALGAMATOR, DENTAL, AC-POWERED EFD 3M DEUTSCHLAND GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other