BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEANEY-BALLENTINE HYST FCP CVD

    MDR report key: 8056644 · Received November 9, 2018

    Report

    Report Number
    2523190-2018-00136
    Event Type
    Malfunction
    Date Received
    November 9, 2018
    Date of Event
    September 1, 2018
    Report Date
    October 19, 2018
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    HCZ
    PMA / PMN Number
    K134047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT SENT IN TO THE MANUFACTURER FOR EVALUATION. THE LOT NUMBER WAS NOT PROVIDED TO PERFORM DHR REVIEW . THE COMPLAINT WAS NOT CONFIRMED. THE ROOT CAUSE TO THE END USER'S EXPERIENCE COULD NOT BE DETERMINED. UDI #: (B)(4).

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2018, A (B)(6) PATIENT WAS PREPPED FOR A TOTAL ABDOMINAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE. THE 505320 HEANEY-BALLENTINE HYST FCP CVD BROKE WHILE IN USE DURING THE PROCEDURE. THERE WAS PATIENT CONTACT, BUT IT IS UNKNOWN IF THERE WAS ANY INJURY OR A SURGICAL DELAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897360 HEANEY-BALLENTINE HYST FCP CVD N/A HCZ INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR