BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RING APPLICATOR SET, 45 DEGREE (085.096)

    MDR report key: 92138 · Received May 16, 1997

    Report

    Report Number
    1121753-1997-00009
    Event Type
    Malfunction
    Date Received
    May 16, 1997
    Date of Event
    May 23, 1996
    Report Date
    May 15, 1997
    Manufacturer
    NUCLETRON CORP.
    Product Code
    HGD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HINGE OR SMALL HOOK (PART #084.501) BROKE OFF OF THE INTRAUTERINE TUBE (PART #084.067) AND REMAINED IN THE PT AFTER THE 45 DEGREE RING APPLICATOR (#085.096) WAS EXTRACTED FROM THE PT. THE BROKEN PIECE WAS LATER RETRIEVED FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RING APPLICATOR SET, 45 DEGREE (085.096) GYNECOLOGICAL APPLICATOR (COMPONENT OF) HGD NUCLETRON CORP. INTRAUTERINE TUBE 40 MM-45 D *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other