BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M ESPE RETRACTION CAPSULE

    MDR report key: 3061035 · Received April 9, 2013

    Report

    Report Number
    9611385-2013-00007
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 12, 2013
    Manufacturer
    3M DEUTSCHLAND GMBH
    Product Code
    MVL
    PMA / PMN Number
    K093721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD, RESULTS, CONCLUSIONS - UNTIL THE DATE OF THE REPORT THE PRODUCT WASN'T RETURNED TO 3M (B)(4). SUCH A CASE CAN OCCUR IF A DENTIST TAKES THE CAPSULE OUT OF THE BLISTER AND STORES IT FOR A TIME BEFORE USING. THUS THE CONSISTENCY OF THE PASTE CAN CHANGE AND HIGHER PUSHING FORCES CAN BE NECESSARY TO PRESS THE PASTE OUT OF THE CAPSULE. THIS IS CLEARLY A HANDLING ERROR. THE CORRECT WAY OF USE IS DESCRIBED IN THE INSTRUCTIONS FOR USE. ACCORDING TO THE DENTIST HE USED THE PRODUCT IN THE CORRECT WAY. THE PRODUCT WAS SENT TO 3M (B)(4) BUT HASN'T ARRIVED AT THE COMPANY YET. FURTHER INFORMATION WILL BE OBTAINED BY EXAMINATION OF THE CONCERNED PRODUCT OR OF A RETAINED SAMPLE. THIS PRODUCT HAS BEEN ASSESSED FOR BIOCOMPATIBILITY AND HAS BEEN FOUND TO BE SAFE FOR ITS INTENDED USE.

    Description of Event or Problem · 1

    ON (B)(6) 2013 3M ESPE WAS INFORMED THAT A 3M ESPE RETRACTION CAPSULE BROKE DURING USE AND PARTS OF THE CAPSULE GOT INTO THE MOUTH OF THE PATIENT. ACCORDING TO THE DENTIST THERE WAS NO HEALTH HAZARD AND THE PARTS OF THE CAPSULE COULD BE EASILY REMOVED WITH THE SUCTION. THE PATIENT DIDN'T NOTICE THE INCIDENT AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144780 3M ESPE RETRACTION CAPSULE RETRACTION CAPSULE MVL 3M DEUTSCHLAND GMBH 486810

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention