BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELLHORN PESS.FLEX.2-1/2

    MDR report key: 17612496 · Received August 24, 2023

    Report

    Report Number
    1216677-2022-00153
    Event Type
    Malfunction
    Date Received
    August 24, 2023
    Date of Event
    April 20, 2022
    Report Date
    August 24, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HHW
    UDI-DI
    00888937006728
    PMA / PMN Number
    K904774
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLARIFICATION TO H6 COMPONENT CODE: THE COMPLAINT UNIT IS A GELLHORN-SHAPED PESSARY. THE COMPLAINT IS AGAINST THE STIFFNESS OF THE MATERIAL AS A WHOLE. INVESTIGATION FINDINGS: THE COMPLAINT PRODUCT WAS MANUFACTURED AT COOPERSURGICAL ON 30/SEP/2020. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO NON-CONFORMITIES RELATED TO THE COMPLAINT CONDITION WERE NOTED. THIS WORK ORDER, HOWEVER, WAS COMPLETED BEFORE THE DUROMETER SPECIFICATION OF THIS PRODUCT WAS REDUCED FROM 60 TO 45. A REVIEW OF THE TWO-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. THERE ARE ADDITIONAL COMPLAINTS FOR THE SAME ISSUE FROM PRODUCT MANUFACTURED IN THE SAME TIMELINE PRIOR TO CORRECTIVE ACTION. THE COMPLAINT PRODUCT WAS NOT RETURNED TO COOPERSURGICAL, THEREFORE, EVALUATION OF THE PRODUCT COULD NOT BE COMPLETED. ROOT CAUSE: THE ROOT CAUSE OF THIS ISSUE HAS BEEN ATTRIBUTED TO A DISCREPANCY IN THE APPROPRIATE DUROMETER OF THE MATERIAL COMPARED TO THE PRODUCT PURCHASED FROM THE SUPPLIER (EIS CORPORATION). CORRECTIVE ACTIONS: THIS ISSUE HAS BEEN ADDRESSED VIA AN ENGINEERING CHANGE. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED VIA COMPANY REPRESENTATIVE "HAVING STIFFNESS ISSUES WITH OUR GELLHORNS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2201168 GELLHORN PESS.FLEX.2-1/2 GELLHORN PESS.FLEX.2-1/2 HHW COOPERSURGICAL, INC. MXPGE2-1/2 293432 00888937006728

    Patients

    Seq Age Sex Outcome Treatment
    1 Female