BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RING, ENDOCAPSULAR

    MDR report key: 16707271 · Received April 7, 2023

    Report

    Report Number
    MW5116485
    Event Type
    Malfunction
    Date Received
    April 7, 2023
    Date of Event
    March 9, 2023
    Report Date
    April 6, 2023
    Manufacturer
    MORCHER GMBH
    Product Code
    MRJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GM
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DESCRIPTION, REPORTED BY THE VENDOR TO THE MANUFACTURER ON 10-MAR-2023: IT WAS REPORTED THAT CTR WAS REMOVED BECAUSE DR. (B)(6) SAID IT WAS BENT. UNKNOWN ON LOT NUMBER OF THE PRODUCT. UNKNOWN PRODUCT CAN COME BACK. PATIENT CONTACT. EMAILED THE REPORTER A FEW TIMES TO OBTAIN ADDITIONAL INFORMATION TO NO AVAIL. ADDITIONAL INFORMATION WAS REQUESTED FROM THE VENDOR BY THE MANUFACTURER ON 16-MAR-2023. ON 03/30/2023 THE VENDOR STATED THAT NO FURTHER INFORMATION WILL BE PROVIDED BY THE ACCOUNT AND THE PRODUCT WILL NOT BE RETURNED. INITIAL REPORTER OF THIS EVENT WITH THE MEDICAL DEVICE FORTIFEYE CTR, MODEL CTR11R (PMA: P010059 S006), WAS: (B)(6) NO INFORMATION (SERIAL NUMBER OR LOT) OF THE USED DEVICE WAS GIVEN BY THE FACILITY. THE PRODUCT WILL NOT BE RETURNED TO THE MANUFACTURER. NO PRODUCT RELATED INVESTIGATION (REVIEW OF DHR AND MEASUREMENT PROTOCOLS) COULD BE CONDUCTED. A TREND ANALYSIS WAS PERFORMED. THE OCCURENCE OF THE PRODUCT PROBLEM SINCE 2014 IS "UNLIKELY". THE TREND ANALYSIS SHOWS AN INDICATION FOR A DECREASING TREND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2019571 RING, ENDOCAPSULAR RING, ENDOCAPSULAR MRJ MORCHER GMBH CTR11R

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown FORTIFEYE CTR11R