BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M (TM) ESPE (TM) RETRACTION CAPSULE

    MDR report key: 2919720 · Received January 11, 2013

    Report

    Report Number
    9611385-2013-00002
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    October 24, 2012
    Report Date
    December 14, 2012
    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: UNTIL THE DATE OF THIS REPORT THE PRODUCT WASN'T RETURNED TO 3M (B)(4). THE DENTIST DISCARDED THE CAPSULES AFTER THE INCIDENT SO THE ORIGINAL LOT-NR. IS NOT KNOWN TO US. AN INTERVIEW WITH THE DENTIST REVEALED, THAT SHE THINKS THAT THE SYMPTOMS COULD BE CAUSED BY THE RETRACTION PASTE BUT SHE STATED THAT IT IS MORE LIKELY THAT THE ADVERSE EVENT HAPPENED AS A RESULT OF AN INTOLERANCE TO ULTRACAIN, A LOCAL ANESTHETIC, WHICH WAS ALSO USED DURING THE TREATMENT OF THE PATIENT. 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. ABOUT 4 HOURS AFTER THE USE OF THE 3M ESPE RETRACTION PASTE, THE PATIENT SUFFERED FROM STRONG SWELLING ON THE LEFT SIDE OF THE FACE, WHICH WAS ALSO REDDENED. ADDITIONALLY THERE WAS HEAT AND TINGLING SENSATION ALL OVER THE FACE. THE AREA AROUND THE EYE WAS DRY AND SCALY. THE SYMPTOMS VANISHED COMPLETELY AFTER FIVE DAYS AND THE PATIENT IS FREE OF COMPLAINTS. NO FURTHER FOLLOW-UP INFORMATION IS CURRENTLY AVAILABLE TO US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17739 3M (TM) ESPE (TM) RETRACTION CAPSULE RETRACTION CAPSULE MVL 3M DEUTSCHLAND GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other