BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO MARK CLIP

    MDR report key: 174645 · Received June 26, 1998

    Report

    Report Number
    MW1014086
    Event Type
    Malfunction
    Date Received
    June 26, 1998
    Date of Event
    June 11, 1998
    Report Date
    June 26, 1998
    Manufacturer
    BIOPSYS MEDICAL, INC.
    Product Code
    MIJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER DEPLOYING METAL CLIP INTO RIGHT BREAST, UPON RETRACTING METAL HUB THAT SURROUNDS THE CLIP, CLIP REMAINED IN BREAST. (PART OF THE OUTER CASING) REMAINED STUCK IN RIGHT BREAST. VERY MISISCULE IN SIZE (2MM). CO REP HERE COLLECTED CLIP & PART OF CASING TO RETURN TO CO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO MARK CLIP Implant CLIP TO MARK SITE FOR BIOPSY MIJ BIOPSYS MEDICAL, INC. BMI-1530 W6278

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other