BEUDAMED
    FDA Adverse Event Other Summary report: N

    GYN DISPOSABLES TENACULUM 356T

    MDR report key: 2094136 · Received April 28, 2011

    Report

    Report Number
    3006365741-2011-00001
    Event Type
    Other
    Date Received
    April 28, 2011
    Date of Event
    July 22, 2009
    Report Date
    April 27, 2011
    Manufacturer
    GYN DISPOSABLES
    Product Code
    HDC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG #356T, LOT # 313967, 314025, 314152 OR 314273 (INCLUDED IN (B)(4), IUD INSERTION KIT, LOT # 29510365). METHOD: PRODUCT WAS NOT RETURNED. EVALUATION BY ANALYZING DESIGN OF TENACULUM VS. PHYSICIAN'S NARRATIVE AND CONSIDERING THAT THERE IS A "LEARNING CURVE" FOR SOME PHYSICIANS. ADDITIONAL INFORMATION: THIS REPORT IS BEING FILED AFTER THE FACT. AT THE TIME GYM DISPOSABLES RECEIVED THE PHYSICIAN'S LETTER, A COMPLAINT WAS OPENED AND INVESTIGATED. GYN DISPOSABLES DID NOT CONSIDER THE EVENT A REPORTABLE EVENT BECAUSE SOME PAIN IS ASSOCIATED WITH THE USE OF ANY TENACULUM AND THE USE OF A CERVICAL BLOCK (LIDOCAINE INJECTION) IS A STANDARD OF CARE FOR SOME PHYSICIANS WHEN THEY USE A TENACULUM. OTHER PHYSICIANS PERFORM A PROCEDURE WITHOUT LIDOCAINE UNLESS THE PATIENT EXPERIENCES EXCESSIVE PAIN. A RECENT AUDIT MADE THE OBSERVATION THAT THIS COMPLAINT SHOULD BE REPORTABLE.

    Description of Event or Problem · 1

    DOCTOR STATED: "I HAD TRIED THE IUD INSERTION KIT (B)(6), AND IT DID NOT WORK. THE TENACULUM WOULD SPLIT AT THE END AND NOT ALLOW ME TO GRASP A SMALL CERVIX ON A NULLIPAROUS WOMAN." "AFTER DISCUSSING THE ISSUE WITH YOUR OFFICE, A DVD WAS SENT TO ME DESCRIBING THE PRODUCT AND ITS CORRECT US (SIC). I VIEWED THE DVD AND THEN ATTEMPTED TODAY TO USE IT AGAIN, BUT HAD THE SAME RESULTS. THE RESULT WAS THAT IT TOOK LONGER TO GRASP THE CERVIX, RESULTED IN SEVERAL STABS, MORE PAIN, AND I HAD TO RESORT TO A CERVICAL BLOCK TO CONTINUE THE PROCEDURE. I HAVE INSERTED LOTS OF THESE IUDS BEFORE AND THIS JUST DOES JUST NOT HELP. IN BOTH CASES, I HAD TO RESORT TO MY AUTOCLAVED STAINLESS STEEL INSTRUMENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYN DISPOSABLES TENACULUM 356T TENACULUM HDC GYN DISPOSABLES 313967

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other DIFFICULTY USING THE TENACULUM OCCURRED DURING| THE INSERTION OF AN IUD IN A NULLIPARIOUS WOMAN.