BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUBE PESSARY W/HOLES #1

    MDR report key: 10711089 · Received October 21, 2020

    Report

    Report Number
    1216677-2020-00240
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    September 18, 2020
    Report Date
    October 21, 2020
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HHW
    PMA / PMN Number
    K904774
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: X-NO SAMPLE RETURNED: X-REVIEW DHR. ANALYSIS AND FINDINGS: WAS THE COMPLAINT CONFIRMED? NO. DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI IN MARCH 2020 UNDER WORK ORDER (B)(4). MANUFACTURING RECORD REVIEW: DHR20MPG001955 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 SHOWED ONE OTHER SIMILAR REPORTED COMPLAINT CONDITION. 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: ACCORDING TO THE IFU, THE CORD IS MEANT TO BE USED AS A GUIDE FOR LOCATING THE PESSARY ONLY AND SHOULD NOT BE PULLED ON TO REMOVE THE PESSARY (SEE ATTACHMENT). BASED ON THE COMPLAINT REPORT, IT IS SUSPECTED THE USER MISTAKENLY USED THE CORD TO REMOVE THE PESSARY WHICH CAUSED IT TO DETACH. CORRECTION AND/OR CORRECTIVE ACTION: NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. NO TRAINING REQUIRED AT THIS TIME. PREVENTATIVE ACTION ACTIVITY: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF OUR REPORTABLE EVENTS, WHICH OCCURRED IN 2020.

    Description of Event or Problem · 0

    REPORT STATED "THE PESSARY CORDON BROKE AFTER A FEW DAYS OF USE, AND THE PATIENT HAD TO GO TO MEDICAL EMERGENCIES TO REMOVE THE PESSARY. THIS PATIENT WAS USED TO WEAR A CUBE PESSARY FROM ANOTHER MANUFACTURER. SHE HAD BEEN WEARING THIS COMPETITOR CUBE PESSARY FOR ONE YEAR BEFORE BUYING THE MILEX CUBE, SO SHE KNEW HOW TO USE A CUBE PESSARY. REF E-COMPLAINT: (B)(4). 1216677-2020-00240. CUBE PESSARY W-HOLES NO 1 MXPECH01 E-COMPLAINT: (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORT STATED, "THE PESSARY CORDON BROKE AFTER A FEW DAYS OF USE, AND THE PATIENT HAD TO GO TO MEDICAL EMERGENCIES TO REMOVE THE PESSARY. THIS PATIENT WAS USED TO WEAR A CUBE PESSARY FROM ANOTHER MANUFACTURER. SHE HAD BEEN WEARING THIS COMPETITOR CUBE PESSARY FOR ONE YEAR BEFORE BUYING THE MILEX CUBE, SO SHE KNEW HOW TO USE A CUBE PESSARY." REF#: (B)(4). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180646 CUBE PESSARY W/HOLES #1 CUBE PESSARY W/HOLES #1 HHW COOPERSURGICAL, INC. MXPECH01 282894

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other