BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELLHORN PESS.FLEX.2-1/2

    MDR report key: 10885481 · Received November 23, 2020

    Report

    Report Number
    1216677-2020-00271
    Event Type
    Malfunction
    Date Received
    November 23, 2020
    Date of Event
    June 30, 2020
    Report Date
    March 2, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INITIATED MANUFACTURER'S INVESTIGATION NO SAMPLE RETURNED REVIEW DHR INSPECT STOCK PRODUCT. *ANALYSIS AND FINDINGS DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI IN FEBRUARY 2020 UNDER WORK ORDER (B)(4). MANUFACTURING RECORD REVIEW DHR20MPG001525 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW INCOMING INSPECTION RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. SERVICE HISTORY RECORD SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWS OTHER COMPLAINTS FOR THIS ISSUE. PRODUCT RECEIPT THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. FUNCTIONAL EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. *CORRECTION AND/OR CORRECTIVE ACTION COOPERSURGICAL DECIDED TO RETURN MANUFACTURING TO THE SUPPLIER (EIS) IN LATE 2020. LONG STEM GELLHORNS WERE QUALIFIED PER (B)(6) AND SHORT STEM GELLHORN PESSARIES WERE QUALIFIED PER (B)(6). IN ADDITION, THE PRINTS FOR THE GELLHORN PESSARIES WERE UPDATED TO REDUCE THE DUROMETER HARDNESS FROM 60 TO 45. *WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    THE PESSARY IS TOO STIFF. GELLHORN PESS FLEX 2 1-2 MXPGE2 1-2 (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE CONDITION REPORTED.

    Description of Event or Problem · 1

    (B)(4). REPORT FORWARDED BY CUSTOMER SERVICE TRUMBULL- THE CUSTOMER HAS ISSUED A CUSTOMER DISSATISFACTION COMPLAINT SOME TIME AGO SAYING THE PESSARIES ARE TOO STIFF. ADDITIONAL COMPLAINT IN REF. TO E-COMPLAINT-(B)(4). 1216677-2020-00271 GELLHORN PESS FLEX 2-1 2 MXPGE2-1 2 E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347435 GELLHORN PESS.FLEX.2-1/2 GELLHORN PESS.FLEX.2-1/2 HHW COOPERSURGICAL, INC. MXPGE2-1/2 276252 00888937006728

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other