BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M CAPMIX

    MDR report key: 7627730 · Received June 21, 2018

    Report

    Report Number
    9611385-2018-00004
    Event Type
    Injury
    Date Received
    June 21, 2018
    Date of Event
    May 21, 2018
    Report Date
    May 22, 2018
    Manufacturer
    3M DEUTSCHLAND GMBH
    Product Code
    EFD
    PMA / PMN Number
    K891064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    DENTAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAPMIX DEVICE IS QUITE OLD AND THE ON/OFF SWITCH WASN'T WORKING PROPERLY ANY MORE. INSTEAD OF SENDING THE DEVICE IN FOR MAINTENANCE THE HUSBAND OF THE NURSE TOOK THE CAPMIX HOME AND TRIED TO FIX THIS BY HIMSELF, WHICH DIDN'T WORK WELL AND LEADED TO EXPOSED CONTACTS AND SUBSEQUENTLY TO THE INJURY. THIS WAS ALSO CONFIRMED BY OUR INTERNAL ANALYSIS OF THE DEVICE. THEREFORE, THERE'S CLEARLY UNDERLYING A HANDLING ERROR.

    Description of Event or Problem · 1

    ON (B)(6) 2018 IT WAS REPORTED TO 3M (B)(4) THAT A CAPMIX DEVICE CAUSED AN ELECTRIC SHOCK AT A DENTAL NURSE, WHICH LEADED TO NUMBNESS AND FEELING DISORDER IN THE RIGHT HAND AND ARM. THE NURSE WENT TO THE DOCTOR THE SAME DAY AFTER THE ACCIDENT. OUR LAST INFORMATION FROM (B)(6) WAS THAT THE SYMPTOMS PERSIST, BUT THE NURSE STARTED TO WORK AGAIN, SO IT CAN BE ASSUMED THAT THE SYMPTOMS ARE NOT SEVERE. HOWEVER, THE INFORMATION ABOUT THE LATEST STATUS IS NOT AVAILABLE TO US. ON (B)(6) 2018 IT WAS REPORTED TO 3M (B)(4) THAT A CAPMIX DEVICE CAUSED AN ELECTRIC SHOCK AT A DENTAL NURSE, WHICH LEADED TO NUMBNESS AND FEELING DISORDER IN THE RIGHT HAND AND ARM. THE NURSE WENT TO THE DOCTOR THE SAME DAY AFTER THE ACCIDENT. OUR LAST INFORMATION FROM (B)(6) WAS THAT THE SYMPTOMS PERSIST, BUT THE NURSE STARTED TO WORK AGAIN, SO IT CAN BE ASSUMED THAT THE SYMPTOMS ARE NOT SEVERE. HOWEVER, THE INFORMATION ABOUT THE LATEST STATUS IS NOT AVAILABLE TO US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467881 3M CAPMIX VACCUM MIXING DEVICE DENTAL EFD 3M DEUTSCHLAND GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other