BEUDAMED
    FDA Adverse Event Summary report: N

    HULKA CLIP

    MDR report key: 5605481 · Received April 25, 2016

    Report

    Report Number
    1418479-2016-00009
    Date Received
    April 25, 2016
    Date of Event
    January 1, 1992
    Report Date
    March 28, 2016
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC)
    Product Code
    KNH
    PMA / PMN Number
    P870080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HAD DEVICES IMPLANTED IN 1992 AND REMOVED IN 2014 (TWO DEVICES PER PACKAGE, ONE FOR EACH FALLOPIAN TUBE). DEVICES WERE NOT RETURNED TO MANUFACTURE FOR INVESTIGATION. DURING THE 22 YEARS THE DEVICES WERE IMPLANTED, PATIENT REPORTED HAVING ISSUE, SPECIFICALLY BACK PAIN AND BLISTERS ON TOES AND/OR FEET. IN ADDITION, PATIENT REVEALED SHE HAD A TOE AMPUTATED ALTHOUGH IT IS UNCLEAR IF DUE TO BLISTERS OR SOME OTHER MEDICAL ISSUE. 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. PATIENT REPORTED HAVING ISSUES DURING THE TIME DEVICES WERE IMPLANTED AND EVENTUALLY HAD THEM REMOVED AFTER 12 YEARS. THIS COMPLAINT WAS RECEIVED ABOUT A WEEK AGO, MDR WILL BE SUBMITTED. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) CONSIDERS THIS REPORT CLOSED. IF ANY NEW INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    PATIENT (INITIAL REPORTER) INFORMED THE FDA AND THE FDA IN TURN NOTIFIED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) WITH VOLUNTARY EVENT REPORT (MW5060595).

    Description of Event or Problem · 1

    RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED A VOLUNTARY EVENT REPORT (MW5060595) FROM THE FOOD AND DRUG ADMINISTRATION (FDA) ON 03/28/2016. PATIENT REPORTED HAVING A TUBAL LIGATION IN (B)(6) 1992 WHEN DEVICES WERE IMPLANTED (PACKAGE CONTAINS TWO CLIPS, ONE FOR EACH FALLOPIAN TUBE). SINCE THE TIME DEVICES WERE IMPLANTED, PATIENT REPORTED "SEVERE BACK PAIN" AND FOR SEVERAL YEARS ALSO DEVELOPED BLISTERS ON HER TOES AND UNDER HER FEET. PATIENT REVEALED SHE HAD A TOE AMPUTATED BUT IT WAS NOT CLEAR IF DUE TO BLISTERS OR OTHER MEDICAL ISSUE. PATIENT HAD THE DEVICES REMOVED IN 2014, TOTAL OF 22 YEARS INSIDE OF PATIENT. PATIENT DOES NOT RESIDE IN THE UNITED STATES. DEVICE MANUFACTURER: RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC), (B)(4). REPACKAGER/RELABELER: RICHARD WOLF (B)(4). RWMIC SUPPLIES NON-STERILE DEVICES (COMPONENTS) TO RW(B)(4). RW(B)(4) IS RESPONSIBLE FOR THE PACKAGING, LABELING AND EO STERILIZATION OF FINISHED PRODUCT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261478 HULKA CLIP HULKA CLIP KNH RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) 4986.90

    Patients

    Seq Age Sex Outcome Treatment
    1 Other