BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MXAPP TRIMO SAN JEL-JECTOR

    MDR report key: 7966334 · Received October 15, 2018

    Report

    Report Number
    1216677-2018-00052
    Event Type
    Malfunction
    Date Received
    October 15, 2018
    Date of Event
    September 25, 2018
    Report Date
    October 15, 2018
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGD
    PMA / PMN Number
    E216669
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    *INVESTIGATION NO SAMPLE RETURNED REVIEW DHR INSPECT STOCK PRODUCT *ANALYSIS AND FINDINGS AN EVALUATION OF THE COMPLAINANT SAMPLES COULD NOT BE CONDUCTED SINCE THEY WILL NOT BE RETURNED. THE APPLICATOR ASSEMBLY IS MADE UP OF THREE COMPONENT PARTS (THE BULB, THE FLYER AND THE TUBE) PURCHASED FROM AND ASSEMBLED BY A SUPPLIER. A REVIEW OF TWO YEAR COMPLAINT HISTORY SHOWS SOME COMPLAINTS FOR THIS ISSUE. A REVIEW OF THE DHR (243208) SHOW NO ABNORMALITIES. A REVIEW OF COOPERSURGICAL INCOMING INSPECTION RECORDS OF THE TUBE OVER THE PAST 2 YEARS SHOWS NO REJECTIONS FOR THIS ISSUE. THE TUBE IS MOLDED BY A SUPPLIER AND HAS 8 CAVITIES. A SAMPLE INSPECTION OF ALL 8 CAVITIES IN STOCK INVENTORY FOUND ALL THE PARTS MET QUALITY REQUIREMENTS AND WERE NOT SHARP AT THE DISTAL END. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. *CORRECTION AND/OR CORRECTIVE ACTION / *PREVENTATIVE ACTION ACTIVITY WILL CONTINUE TO MONITOR FOR TRENDING.

    Description of Event or Problem · 0

    "PATIENT WENT TO USE THE APPLICATOR AND THE END WAS SHARP AND SCRAPE/CUT HER ON THE INSIDE OF HER VAGINAL CANAL. " REFERENCE E-COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT CONDITION REPORTED IS CURRENTLY BEING INVESTIGATED. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORTED WILL BE FILED.

    Description of Event or Problem · 1

    "PATIENT WENT TO USE THE APPLICATOR AND THE END WAS SHARP AND SCRAPE/CUT HER ON THE INSIDE OF HER VAGINAL CANAL. " (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804993 MXAPP TRIMO SAN JEL-JECTOR TRIMO SAN APPLICATOR HGD COOPERSURGICAL, INC. MXAPP 6628

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other