BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HULKA CLIPS

    MDR report key: 9918527 · Received April 2, 2020

    Report

    Report Number
    1418479-2020-00009
    Event Type
    Injury
    Date Received
    April 2, 2020
    Date of Event
    October 31, 2001
    Report Date
    March 2, 2020
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    KNH
    UDI-DI
    00861523000102
    PMA / PMN Number
    P870080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INFORMATION WAS NOT PROVIDED. THE REPORTER WILL BE CONTACTED IN AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP WILL BE PROVIDED.

    Description of Event or Problem · 1

    ON MARCH 02, 2020, RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) RECEIVED MEDWATCH REPORT # MW5092897.. THE PATIENT REPORTED THEY HAD THEIR TUBES TIED AND FOR MANY YEARS THEY SUFFERED DIFFERENT SYMPTOMS AND PROBLEMS. PATIENT REPORTED HAVING TUBES TIED TWELVE AND A HALF (12.5) YEARS LATER AND DETERMINED THAT THE SYMPTOMS THEY WERE HAVING AND ISSUES WERE A REACTION TO THE HULKA CLIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381306 HULKA CLIPS TUBAL OCCLUDING DEVICE KNH RICHARD WOLF MEDICAL INSTRUMENTS CORP. 4986.90 00861523000102

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R