BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HULKA CLIP

    MDR report key: 6474246 · Received April 7, 2017

    Report

    Report Number
    1418479-2017-00004
    Event Type
    Injury
    Date Received
    April 7, 2017
    Date of Event
    June 1, 1993
    Report Date
    March 13, 2017
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC)
    Product Code
    KNH
    UDI-DI
    00861523000102
    PMA / PMN Number
    P870080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HAD DEVICES IMPLANTED IN (B)(6) 1993 (TWO DEVICES PER PACKAGE, ONE FOR EACH FALLOPIAN TUBE). DEVICES WERE NOT RETURNED TO MANUFACTURER FOR INVESTIGATION. DURING THE TIME DEVICES WERE IMPLANTED, PATIENT REPORTED HAVING "HEALTH ISSUES." NO OTHER INFORMATION GIVEN (TEST RESULTS, DOCTOR DIAGNOSIS...) RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) IS UNABLE TO CONFIRM COMPLAINT. THERE HAS BEEN TWO SIMILAR COMPLAINTS ON THIS DEVICE IN THE LAST FIFTEEN YEARS, MDR1418479-2016-00009 & MDR1418479-2016-00012. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) CONSIDERS THIS REPORT CLOSED. IF ANY NEW INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED A PHONE CALL FROM A PATIENT INDICATING SHE HAD A DEVICE IMPLANTED AND NOW HAS "MANY HEALTH ISSUES." PATIENT REPORTED HAVING A TUBAL LIGATION IN (B)(6) 1993 WHEN DEVICES WERE IMPLANTED (PACKAGE CONTAINS TWO CLIPS, ONE FOR EACH FALLOPIAN TUBE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252988 HULKA CLIP HULKA CLIP KNH RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) 4986.90 00861523000102

    Patients

    Seq Age Sex Outcome Treatment
    1 Other