BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAATZ PESS 3-1/4

    MDR report key: 10936834 · Received December 2, 2020

    Report

    Report Number
    1216677-2020-00286
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    June 30, 2020
    Report Date
    February 8, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HHW
    UDI-DI
    00888937008715
    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. DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI IN NOVEMBER 2019 UNDER WORK ORDER 263888. MANUFACTURING RECORD REVIEW: DHR20MPG000410 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 DID SHOW SOME OTHER COMPLAINTS 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. CORRECTIVE ACTIONS: COOPERSURGICAL DECIDED TO RETURN MANUFACTURING TO THE SUPPLIER (EIS) IN LATE 2020. LONG STEM GELLHORNS WERE QUALIFIED PER VAL-20-0285 AND SHORT STEM GELLHORN PESSARIES WERE QUALIFIED PER VAL-20-0289. AS STATED PREVIOUSLY, A SECONDARY OPERATION REMOVES THE STEM TO MAKE IT A SHAATZ PESSARY. 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 CUSTOMER HAS ISSUED A CUSTOMER DISSATISFACTION COMPLAINT SOME TIME AGO SAYING THE PESSARIES ARE TOO STIFF." 1216677-2020-00286-1 MXPSH3-1-4-SHAATZ PESS 3-1-4 (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    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 (B)(4). SHAATZ PESS 3-1/4 MXPSH3-1/4 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1402325 SHAATZ PESS 3-1/4 SHAATZ PESS 3-1/4 HHW COOPERSURGICAL, INC. MXPSH3-1/4 263888 00888937008715

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other