BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROFLEX HD HYSTEROSCOPIC DISTENTION TUBING SET

    MDR report key: 1253403 · Received December 3, 2008

    Report

    Report Number
    1213643-2008-00538
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    October 30, 2008
    Report Date
    November 7, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    HIG
    PMA / PMN Number
    K982867
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE WILL SUBMIT A FOLLOW UP REPORT WHEN/IF PRODUCT IS RETURNED FOR EVALUATION OR ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    DURING HYSTEROSCOPY WITH UTERINE BIOPSY PROCEDURE, THE HYDROFLEX HD TUBING WAS REPORTED TO LEAK IN THE AREA WHERE THE YELLOW CONNECTORS MEET. COMPLAINANT REPORTED THIS SUBSEQUENTLY LED TO LOSS OF UTERINE DISTENTION AND HYSTEROSCOPIC VISUALIZATION. THE PATIENT HAD A 600 ML BLOOD LOSS DURING THE PROCEDURE. THE PATIENT DID NOT REQUIRE A BLOOD TRANSFUSION AND HAD NO UNTOWARD SYMPTOMS RELATED TO THE BLOOD LOSS AND REMAINED IN STABLE CONDITION. THE PATIENT HAD VAGINAL PACKING PLACED. SHE WAS ADMITTED FOR OBSERVATION, AND WAS DISCHARGED TO HOME WITHIN 48 HOURS. THE PATIENT IS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROFLEX HD HYSTEROSCOPIC DISTENTION TUBING SET HIG DAVOL INC., SUB. C.R. BARD, INC. NA JUSHF079

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O VAGINAL PACKING POST-OPERATIVELY