BEUDAMED
    FDA Adverse Event Summary report: N

    HULKA CLIP

    MDR report key: 5641689 · Received May 9, 2016

    Report

    Report Number
    1418479-2016-00012
    Date Received
    May 9, 2016
    Date of Event
    October 31, 2001
    Report Date
    April 14, 2016
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC)
    Product Code
    KNH
    PMA / PMN Number
    P870080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HAD DEVICES IMPLANTED IN 2001 AND REMOVED IN 2013 (TWO DEVICES PER PACKAGE, ONE FOR EACH FALLOPIAN TUBE). DEVICES WERE NOT RETURNED TO MANUFACTURER FOR INVESTIGATION. DURING THE ALMOST 11 YEARS THE DEVICES WERE IMPLANTED, PATIENT REPORTED HAVING "PELVIC PAINS, ABDOMINAL PAINS, INFECTIONS ETC." RWMIC EMAILED PATIENT AND REQUESTED DOCTOR DIAGNOSIS, NO RESPONSE AS OF 05/09/2016. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) IS UNABLE TO CONFIRM COMPLAINT. THERE HAS BEEN ONE SIMILAR COMPLAINT ON A SIMILAR DEVICE IN THE LAST FIFTEEN YEARS, MDR1418479-2016-00009. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) CONSIDERS THIS REPORT CLOSED. IF ANY NEW INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED A VOLUNTARY EVENT REPORT (MW5060833) FROM THE (B)(4)) ON (B)(6) 2016. PATIENT REPORTED HAVING A TUBAL LIGATION IN (B)(6) 2001 WHEN DEVICES WERE IMPLANTED (PACKAGE CONTAINS TWO CLIPS, ONE FOR EACH FALLOPIAN TUBE). SINCE THE TIME DEVICES WERE IMPLANTED, PATIENT REPORTED "PELVIC PAINS, ABDOMINAL PAINS AND INFECTIONS ETC". PATIENT HAD THE DEVICES REMOVED IN (B)(6) 2013, 11 YEARS 8 MONTHS INSIDE OF PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296512 HULKA CLIP HULKA CLIP KNH RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) 4986.90

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other