BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MX5030 TRIMO SAN

    MDR report key: 8508461 · Received April 12, 2019

    Report

    Report Number
    1216677-2019-00055
    Event Type
    Malfunction
    Date Received
    April 12, 2019
    Date of Event
    April 1, 2019
    Report Date
    December 12, 2019
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGD
    PMA / PMN Number
    E216669
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE E-COMPLAINT-(B)(4). INVESTIGATION: X-NO SAMPLE RETURNED, X-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 NO COMPLAINTS FOR THIS ISSUE. THE COMPLAINANT DID NOT DISCLOSE A LOT NUMBER. A REVIEW OF COOPERSURGICAL INCOMING INSPECTION RECORDS SHOWS NO REJECTIONS FOR THIS ISSUE. THE TUBE IS MOLDED BY A SUPPLIER AND HAS 8 CAVITIES. A SAMPLE 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; NONE. NO ACTION IS REQUIRED AT THIS TIME. CONTINUE TO MONITOR FOR TRENDING. SHOULD THE SAMPLES BE RETURNED, THIS COMPLAINT WILL BE REOPENED AND RE-EVALUATED. PREVENTATIVE ACTION ACTIVITY: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS.

    Description of Event or Problem · 0

    "ORDERED TRIMOSAN FROM WALMART.COM. SAID APPLICATOR SCRATCHED HER DID NOT GIVE DETAILS." 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

    "ORDERED TRIMOSAN FROM (B)(6). SAID APPLICATOR SCRATCHED HER DID NOT GIVE DETAILS." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300494 MX5030 TRIMO SAN TRIMO SAN HGD COOPERSURGICAL, INC. MX5030 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other