BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIONIX LIGHTED MICROLOOP

    MDR report key: 931755 · Received October 19, 2007

    Report

    Report Number
    MW5004151
    Event Type
    Injury
    Date Received
    October 19, 2007
    Date of Event
    October 5, 2007
    Report Date
    October 19, 2007
    Product Code
    JYG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    STAFF WERE TRYING NEW LIGHTED EAR CURETTE ON SALLY TO SEE HOW IT WORKED BEFORE USING ON RESIDENT OF FACILITY. LONG PLASTIC CURETTE ATTACHES TO LIGHT SOURCE, DID NOT ATTACH SECURELY AND IT BECAME PROJECTILE AND SHOT INTO SALLY'S EAR PUNCTURING HER EAR DRUM. COMPANY CALLED AND STATED THIS HAS HAPPENED BEFORE TO ANOTHER CUSTOMER. EXACT BRAND BIONIX LIGHTED MICROLOOP 3MM DIAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIONIX LIGHTED MICROLOOP EAR CURETTE JYG 2220

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Disability