BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RING W/SUPP.#6 83MM 3-1/4

    MDR report key: 8025942 · Received October 31, 2018

    Report

    Report Number
    1216677-2018-00067
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    June 14, 2018
    Report Date
    March 3, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HHW
    PMA / PMN Number
    K904774
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CLARIFICATION TO H.6. COMPONENT CODE: UNIT IS A ONE-PIECE PESSARY. CLARIFICATION TO D.3. LOT NUMBER: LOT # 227732 AND 227730 WERE IDENTIFIED AS POSSIBLE LOT NUMBERS FOR THE COMPLAINT PRODUCT. INVESTIGATION: AN EVALUATION OF THE COMPLAINANT SAMPLES COULD NOT BE CONDUCTED SINCE IT WILL NOT BE RETURNED. A REVIEW OF TWO YEAR COMPLAINT HISTORY SHOWS NO COMPLAINTS. THIS PRODUCT IS MOLDED AND PACKAGED AT COOPERSURGICAL TRUMBULL FACILITY AND IS 100% VISUALLY INSPECTED PRIOR TO PACKAGING. THE LOT NUMBERS IN QUESTION WERE MANUFACTURED IN JUNE 2017 AND SENT TO THE CUSTOMER IN LATE JULY/EARLY AUGUST 2017. WITHOUT THE RETURNED SAMPLE, A DEFINITIVE ROOT CAUSE OF THE ISSUE CANNOT BE DETERMINED AT THIS TIME AND THUS, THE COMPLAINT IS NOT CONFIRMED. COOPERSURGICAL WILL CONTINUE TO MONITOR FOR TRENDING. CORRECTIVE ACTIONS: THIS COMPLAINT WILL BE REOPENED AND RE-EVALUATED SHOULD THE SAMPLES BE RETURNED. WILL CONTINUE TO MONITOR FOR TRENDING.

    Description of Event or Problem · 0

    PATIENT REPORTED "THIS NEW PESSARY WAS TOO STIFF AND AFTER THREE TRIES HER GYNECOLOGIST COULD NOT INSERT IT," "SHE TRIED 3 TIMES TO INSERT PESSARY BUT IT WOULD NOT GO INTO PLACE AND EVERY TIME SHE WAS HURTING ME AND I WAS BLEEDING. SO SHE STOPS..." (B)(4).

    Additional Manufacturer Narrative · 1

    COOPER SURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE DEVICE INVOLVED IN THE COMPLAINT HAS NOT YET BEEN RETURNED BY THE CUSTOMER FOR EVALUATION. ONCE THE DEVICE IS RECEIVED BY COOPER SURGICAL INC. THE INVESTIGATION WILL BE COMPLETED AND A FOLLOW-UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    "THIS NEW PESSARY WAS TOO STIFF AND AFTER THREE TRIES HER GYNECOLOGIST COULD NOT INSERT IT" "SHE TRIED 3 TIMES TO INSERT PESSARY BUT IT WOULD NOT GO INTO PLACE AND EVERY TIME SHE WAS HURTING ME AND I WAS BLEEDING. SO SHE STOPS..." TWO MXPRS06 PESSARIES WERE PURCHASED BY THE ABOVE ACCOUNT HOWEVER SINCE THE PRODUCT IS NOT BEING RETURNED WE CAN NOT DEFINITIVELY DETERMINE WHICH OF THE TWO WAS THE PRODUCT INVOLVED IN THE INCIDENT. LOT # 227732 OR 227730. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862995 RING W/SUPP.#6 83MM 3-1/4 RING W/SUPP.#6 83MM 3-1/4 HHW COOPERSURGICAL, INC. MXPRS06 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other