BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CALDERA

    MDR report key: 24817606 · Received April 8, 2026

    Report

    Report Number
    MW5186467
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    February 16, 2022
    Report Date
    April 4, 2026
    Manufacturer
    CALDERA MEDICAL, INC.
    Product Code
    PWJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RECEIVED POP MESH. VIA DA VINCI ROBOT. THE MESH PROTRUDED THROUGH AND ERODED IN MY BODY. CAUSED ONGOING SEVERE MEDICAL LIFE THREATENING INJURIES. THE MESH WAS IMPROPERLY PLACED BY DA VINCI AND SURGEON. IT HAS ERODED AS WELL. THE MATERIAL IS TOXIC FOR HUMANS BODY. MANY MASSIVE INFECTIONS THROUGHOUT THE BODY . BOTH FUNGAL AND BACTERIAL PARTIAL REMOVAL . NEED FULL REMOVAL. PT CODES: 2419, 1924, 1735, 1750. DEVICE CODES: 1214, 1670, 2682, 2616. REF: MW5186466.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21780 CALDERA INSTRUMENTATION, SURGICAL MESH, UROGYNECOLOGIC, STRESS URINARY INCONTINENCE PWJ CALDERA MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Disability| R| L| H| O