BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MXAPP TRIMO SAN JEL-JECTOR

    MDR report key: 11649904 · Received April 12, 2021

    Report

    Report Number
    1216677-2021-00065
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    March 5, 2021
    Report Date
    November 14, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGD
    PMA / PMN Number
    E216669
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION X-NO SAMPLE RETURNED X-REVIEW DHR *ANALYSIS AND FINDINGS DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS PURCHASED FROM A SUPPLER (CARCLO) AND PACKAGED BY CSI IN DECEMBER 2020. MANUFACTURING RECORD REVIEW THE REPORTED LOT NUMBER (8320) WAS USED IN THREE WORK ORDERS ((B)(4)). DHR'S FOR THESE WORK ORDERS WERE REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW INCOMING INSPECTION RECORD REVIEW NOT APPLICABLE AS THIS PRODUCT IS ON SHIP TO STOCK. A REVIEW OF NCMR'S FOR THE PAST TWO YEARS DID NOT SHOW SIMILAR REPORTED COMPLAINT CONDITIONS. SERVICE HISTORY RECORD SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW A REVIEW OF THE 2-YEAR COMPLAINT HISTORY DID NOT SHOW SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL 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 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 ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. *CORRECTION AND/OR CORRECTIVE ACTION COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    THE USAGE OF THE APPLICATOR FEELS LIKE GLASS AND HAS CAUSE SOME VAGINAL BLEEDING. 1216677-2021-00065 JEL JECTOR APPLICATOR MXAPP E-COMPLAINT-(B)(4).

    Additional Manufacturer Narrative · 1

    COOPESURGICAL , INC. IS CURRENLTY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    THE USAGE OF THE APPLICATOR FEELS LIKE GLASS AND HAS CAUSE SOME VAGINAL BLEEDING . JEL JECTOR APPLICATOR MXAPP. E-COMPLAINT- (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551395 MXAPP TRIMO SAN JEL-JECTOR TRIMO SAN APPLICATOR HGD COOPERSURGICAL, INC. MXAPP 8320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other