BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARINR

    MDR report key: 2953495 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01152
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 20, 2012
    Report Date
    January 26, 2026
    Manufacturer
    MPRI
    Product Code
    DRF
    PMA / PMN Number
    K951347
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS USED AFTER THE USE BY DATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56634 MARINR CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF MPRI 072402

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR