BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DESARA ONE

    MDR report key: 23419256 · Received October 29, 2025

    Report

    Report Number
    3003990090-2025-01590
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    February 25, 2025
    Report Date
    October 29, 2025
    Manufacturer
    CALDERA MEDICAL INC.
    Product Code
    PAH
    UDI-DI
    00890594000964
    PMA / PMN Number
    K191416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION BECAUSE IT HAD BEEN IMPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO NONCONFORMANCE'S, AND ALL DEVICES MET THE ACCEPTANCE CRITERIA AND SPECIFICATIONS BEFORE THEIR RELEASE. THE DETAILS OF THE COMPLAINT DO NOT CLARIFY WHETHER THE REPORTED EVENT IS RELATED TO THE DEVICE ITSELF, THE SURGICAL TECHNIQUE, OR THE EXPERIENCE OF THE SURGEON. UNFORTUNATELY, NO ADDITIONAL INFORMATION COULD BE OBTAINED FROM THE USER. THIS REPORT CONSIDER AS PART OF CAPA: CA25-512. THE MANUFACTURING NUMBER IS C25-2759.

    Description of Event or Problem · 0

    ACCORDING TO SALES REPRESENTATIVE, THE DESARA ANCHOR DETACHED FROM THE MESH DURING PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2686820 DESARA ONE MESH PAH CALDERA MEDICAL INC. Q12003 00890594000964

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female