BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARA PROBE

    MDR report key: 19519438 · Received June 12, 2024

    Report

    Report Number
    1216677-2024-00026
    Event Type
    Injury
    Date Received
    June 12, 2024
    Date of Event
    April 9, 2024
    Report Date
    August 14, 2024
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    MNB
    UDI-DI
    00888937026887
    PMA / PMN Number
    P160047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE LOCATION IS UNKNOWN, CUSTOMER HAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    MANUFACTURING RECORD REVIEW: RECORDS FOR LOT M-220729-06 (W/O (B)(4)) WERE REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: NOT APPLICABLE. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE COMPLAINT DATA REVEALS ONE COMPLAINT INVOLVING A MARA TREATMENT. THE PATIENT SUFFERED A BURN AND DEVELOPED A VAGINAL INFECTION DIAGNOSED AS BACTERIAL VAGINITIS. HOWEVER, IN THIS CASE, NO BURNS WERE REPORTED. 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. FUNCTIONAL EVALUATION: EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. ROOT CAUSE: NO DEFINITIVE ROOT CAUSE FOR THIS ISSUE COULD BE RELIABLY DETERMINED AT THIS TIME, THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND NO FURTHER EVIDENCE TO SUPPORT THE COMPLAINT CONDITION WAS PROVIDED. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A MARA ABLATION PROCEDURE ON (B)(6) 2024. FIVE WEEKS POST PROCEDURE, THE PATIENT UNDERWENT A HYSTERECTOMY DUE TO A SIGNIFICANT UTERINE INFECTION. DOCTOR UNSURE IF THE INFECTION IS RELATED TO THE MARA PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE. . DDK-16-050 MARA PROBE (B)(4).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157115 MARA PROBE WATER VAPOUR ENDOMETRIAL-ABLATION APPLICATOR MNB COOPERSURGICAL, INC. DDK-16-050 M-220921-02 00888937026887

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R