BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M (TM) ESPE (TM) RETRACTION CAPSULE

    MDR report key: 3181385 · Received June 14, 2013

    Report

    Report Number
    9611385-2012-00009
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 15, 2013
    Manufacturer
    3M DEUTSCHLAND GMBH
    Product Code
    MVL
    PMA / PMN Number
    K093721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD, RESULTS AND CONCLUSIONS: THE PRODUCT WASN'T RETURNED TO 3M (B)(4). THE DENTIST DISCARDED THE CAPSULES AFTER THE INCIDENT, BUT INFORMED US ABOUT THE ORIGINAL LOT-NR. AN EXAMINATION OF A RESERVE SAMPLE OF THE SAME LOT SHOWED THAT THERE WAS NO DEVIATION IN THE SPECIFICATION OF THE DEVICE. IN A FOLLOW-UP INTERVIEW THE DENTIST STATED, THAT THE PATIENT HAD EPISODES OF NAUSEA, DIZZINESS, AND CIRCULATORY ALREADY BEFORE THE TREATMENT, BUT THIS TIME THE SYMPTOMS COULD BE PROVOKED BY THE TREATMENT WITH THE RETRACTION PASTE. IT IS HIGHLY PROBABLY THAT NOT THE MATERIAL ITSELF CAUSED THE SYMPTOMS BUT A STATE OF ANXIETY DURING THE TREATMENT AS THE USAGE OF THE RETRACTION PASTE CAN BE UNPLEASANT. 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)(4) 2013 3M (B)(4) WAS INFORMED ABOUT A ADVERSE EFFECT THAT OCCURRED AFTER THE USE OF A 3M (TM) ESPE (TM) RETRACTION CAPSULE. DURING THE USE OF THE 3M (TM) ESPE (TM) RETRACTION PASTE, THE PATIENT SUFFERED FROM NAUSEA, DIZZINESS, AND CIRCULATORY INSTABILITY. THE SYMPTOMS LASTED FOR ABOUT ONE DAY AND THEN VANISHED COMPLETELY. CURRENTLY, THE PATIENT IS FREE OF COMPLAINTS. IN A FOLLOW-UP INTERVIEW THE DENTIST STATED, THAT THE PATIENT HAD EPISODES OF NAUSEA, DIZZINESS, AND CIRCULATORY ALREADY BEFORE THE TREATMENT, BUT THIS TIME THE SYMPTOMS COULD BE PROVOKED BY THE TREATMENT WITH THE RETRACTION PASTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271502 3M (TM) ESPE (TM) RETRACTION CAPSULE RETRACTION CAPSULE MVL 3M DEUTSCHLAND GMBH 494971

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other