BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DONUT PESS 2-3/4 IN #3

    MDR report key: 10904554 · Received November 25, 2020

    Report

    Report Number
    1216677-2020-00275
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    June 30, 2020
    Report Date
    March 7, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HHW
    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

    CLARIFICATION TO H.6. COMPONENT CODE: THE UNIT IS A DONUT-SHAPED PESSARY AND THE COMPLAINT IS AGAINST THE MATERIAL STIFFNESS. INVESTIGATION: DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI IN (B)(6) 2020 UNDER WORK ORDER (B)(4). MANUFACTURING RECORD REVIEW (B)(6) 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 ONE OTHER COMPLAINT FOR THIS ISSUE. PRODUCT RECEIPT THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION 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 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. ROOT CAUSE QUALITY ENGINEERING, MANUFACTURING, MARKETING, AND PRODUCT SURVEILLANCE CONDUCTED AN INVESTIGATION INTO THE RECENT COMPLAINTS REGARDING THE HARDNESS AND RIGIDITY OF THE PESSARY PRODUCT LINE. THERE WERE NO SPECIFICATION CHANGES IN THE LAST 2 YEARS. RETURNED PRODUCT FROM HISTORICAL COMPLAINT INVESTIGATIONS AND SAMPLE PRODUCT FROM FINISHED GOODS INVENTORY WERE EVALUATED AND THE REPORTED CONDITION COULD NOT BE DUPLICATED. THE PRODUCTS WERE FOUND TO MEET ALL APPROVED RELEASED SPECIFICATIONS. IT SHOULD BE NOTED THAT THIS PRODUCT WAS ORIGINALLY MANUFACTURED FOR COOPERSURGICAL BY A SUPPLIER UNTIL MID-2017. MANUFACTURING WAS MOVED TO COOPERSURGICAL AND VALIDATED IN (B)(6) 2017 USING A NEW SILICONE SUPPLIER. IT IS SUSPECTED THE CUSTOMER NOTICED THE CURRENT PRODUCTION PESSARY WAS SLIGHTLY HARDER THAN THE PREVIOUSLY RECEIVED SUPPLIER PESSARY. IT SHOULD ALSO BE NOTED THAT THE CURRENT SILICONE SUPPLIER PROVIDES CERTIFICATIONS ON EVERY SHIPMENT WITH DUROMETER HARDNESS TESTING PER WHICH VERIFIES DUROMETER SPECIFICATIONS ARE MET. BASED UPON AN ANALYSIS OF HISTORICAL RETURNED/COMPLAINT PRODUCT, STOCK PRODUCT, DHR REVIEW AND CERTIFICATES OF CONFORMANCE, THE REPORTED COMPLAINT CONDITION COULD NOT BE CONFIRMED. CORRECTIVE ACTION: A CAPA WAS OPENED TO DETERMINE IF CUSTOMER OBSERVATIONS WITH REGARD TO PESSARY DUROMETER WARRANT FURTHER PRODUCT ENHANCEMENTS.

    Description of Event or Problem · 0

    COMPANY REPRESENTATIVE REPORTED "THE CUSTOMER HAS ISSUED A CUSTOMER DISSATISFACTION COMPLAINT SOME TIME AGO SAYING THE PESSARIES ARE TOO STIFF." (B)(4).

    Additional Manufacturer Narrative · 1

    COOPER SURGICAL, INC. IS CURRENTLY INVESTIGATING THE CONDITION REPORTED.

    Description of Event or Problem · 1

    E-COMPLAINT: (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). 1216677-2020-00275 DONUT PESS 2-3 4 IN NO 3 MXPDO03 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372247 DONUT PESS 2-3/4 IN #3 DONUT PESS 2-3/4 IN #3 HHW COOPERSURGICAL, INC. MXPDO03 262774

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other