BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M(TM) ESPE(TM) RETRACTION CAPSULE

    MDR report key: 2888496 · Received December 18, 2012

    Report

    Report Number
    9611385-2012-00008
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 21, 2012
    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 AND CONCLUSIONS: UNTIL THE DATE OF THIS REPORT THE PRODUCT WASN'T RETURNED TO 3M (B)(4). AS THE SYMPTOMS VANISHED IMMEDIATELY AFTER THE REMOVAL OF THE PASTE, IT CAN BE CONCLUDED THAT THE PRODUCT REALLY CAUSED THE SYMPTOMS. THE TYPE OF REACTION AND THE CLINICAL HISTORY OF THE PRODUCT DO NOT INDICATE AN ALLERGIC REACTION. 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 AN ADVERSE EFFECT THAT OCCURRED DURING THE USE OF A 3M (TM) ESPE (TM) RETRACTION CAPSULE. DURING APPLICATION THE PATIENT REACTED WITH A TETANY, ATTACK OF SWEATING, INSTABLE CIRCULATION, PANIC ATTACKS AND PAIN IN THE AREA OF THE SULCUS. THE SYMPTOMS STARTED WHEN THE RETRACTION PASE WAS APPLIED AND STOPPED QUICKLY AFTER THE REMOVAL OF THE PASTE. THE EVENT LASTS FOR APPROXIMATELY 15 - 20 MINUTES. AFTER THIS THE PATIENT FULLY RECOVERED AND THERE ARE NO LONG-TERM EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M(TM) ESPE(TM) RETRACTION CAPSULE RETRACTION CAPSULE MVL 3M DEUTSCHLAND GMBH 493136

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other