BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5MM SINGLE INCISION APPLICATOR

    MDR report key: 1924710 · Received December 6, 2010

    Report

    Report Number
    8021955-2010-00002
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    October 19, 2010
    Report Date
    November 29, 2010
    Manufacturer
    FEMCARE-NIKOMED LTD
    Product Code
    KNH
    PMA / PMN Number
    P920046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT ALSO REPORTED BY FEMCARE-(B)(4) - REPORT #1216677-2010-0007. UNIT WAS EVALUATED BY COOPER SURGICAL SERVICE AND REPAIR DEPARTMENT. THE FILSHIE CLIP APPLICATOR WAS FOUND TO FUNCTION PROPERLY AND THE ALLEGED FAILURE COULD NOT BE DUPLICATED. DEVICE PASSED ALL PERFORMANCE TESTS AND THE DEVICE WAS WITHIN SPECIFICATION. FEMCARE-(B)(4). COOPER SURGICAL INC (B)(4).

    Description of Event or Problem · 1

    WHEN PULLING THE APPLICATOR BACK FROM APPLYING THE CLIP, THE FALLOPIAN TUBE WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MM SINGLE INCISION APPLICATOR FILSHIE CLIP APPLICATOR KNH FEMCARE-NIKOMED LTD FE-5SI-880

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention