BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M ESPE RETRACTION CAPSULE

    MDR report key: 2917648 · Received January 8, 2013

    Report

    Report Number
    9611385-2013-00001
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    3M DEUTSCHLAND GMBH
    Product Code
    MVL
    PMA / PMN Number
    K093721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    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) 2012, 3M ESPE WAS INFORMED ABOUT A ADVERSE EFFECT THAT OCCURRED AFTER THE USE OF A 3M ESPE RETRACTION CAPSULE. DURING THE USE OF THE 3M ESPE RETRACTION PASTE, THE DENTIST INADVERTENTLY INJECTED THE PASTE INTO MUCOSAL TISSUE AS EVIDENCED BY A PURPLISH COLOR IN THE TISSUE. UPON FOLLOW-UP A WEEK LATER, IT WAS LEARNED THAT THE AFFECTED TISSUE HAD NECROSED AND REQUIRED INTERVENTION TO SLOUGH IT OFF THUS REMOVING THE INJECTED RETRACTION PASTE. THE DENTIST PLACED ONE STITCH IN THE AFFECTED AREA. NO FURTHER FOLLOW-UP INFORMATION IS CURRENTLY AVAILABLE ON THE PT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10050 3M ESPE RETRACTION CAPSULE RETRACTION CAPSULE MVL 3M DEUTSCHLAND GMBH 482590

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R