BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HULKA CLIP

    MDR report key: 12860461 · Received November 23, 2021

    Report

    Report Number
    1418479-2021-00051
    Event Type
    Injury
    Date Received
    November 23, 2021
    Report Date
    October 22, 2021
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP
    Product Code
    KNF
    PMA / PMN Number
    P870080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RWMIC WILL SUBMIT A FOLLOW-UP REPORT WHEN NEW INFORMATION/CONFIRMATION OF HULKA CLIP IS RECEIVED. THE PATIENT MENTIONED THAT SHE WAS CONTACTING THE HOSPITAL TO GET HER MEDICAL RECORDS.

    Description of Event or Problem · 0

    ON 10/22/2021, RWMIC RECEIVED A CALL FROM A WOMEN WHO THINKS THAT SHE MAY HAVE HAD THE HULKA CLIP IMPLANTED IN HER ABOUT 12 YEARS AGO IN (B)(6). BELOW IS A LIST OF SYMPTOMS REPORTED TO RWMIC CUSTOMER SERVICE. CHEMICAL PREGNANCY. IRREGULAR HORMONE IMBALANCE. INFLAMMATION OF THE FALLOPIAN TUBE PAINFUL MENSTRAL CYCLE. ON 10/25/2021, RWMIC CONTACTED THE PATIENT FOR MORE INFORMATION. THE PATIENT EXPLAINED THAT SHE AND HER GYN DOCTOR WERE LOOKING INTO OTHER METHODS OF STERILIZATION AND THE DOCTOR CAME ACROSS VARIOUS INFORMATION ABOUT THE HULKA CLIP INCLUDING RECALL. THE DOCTOR RECOMMENDED THAT SHE (THE PATIENT) DO MORE RESEARCH. DURING THE CALL THE PATIENT MENTIONED THAT SHE HAD THE DEVICES IMPLANTED IN 2008, SHE DID NOT KNOW HOW MANY DEVICES WERE IMPLANTED. MS. (B)(6) HAS BEEN TAKING A LOT OF IBUPROFEN/TYLENOL FOR THE PAIN AND IT IS DOING DAMAGE; CAUSING HER KIDNEYS TO BLEED. MS. (B)(6) WANTS TO HAVE THE DEVICES REMOVED AND WANTED MORE INFORMATION ABOUT THE RECALL TO SEE IF THAT WAS THE REASON FOR HER PAIN AND/OR TO HELP WITH INSURANCE COST FOR REMOVAL. RWMIC PROVIDED HIGH LEVEL INFORMATION FOR THE RECALL, BOTH RECALLS WERE FOR MANUFACTURING ISSUES. RWMIC ALSO PROVIDED DEVICE MATERIAL INFORMATION. MS. (B)(6) APPRECIATED THE CALL AND SAID THAT SHE WILL WORK WITH HER DOCTORS OFFICE TO COLLECT MORE INFORMATION. DEVICE PART NUMBER, LOT NUMBER, ETC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1760625 HULKA CLIP CONTRCEPTIVE TUBAL OCCLUSION DEVICE KNF RICHARD WOLF MEDICAL INSTRUMENTS CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other