BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIMED RADIOPAQUE

    MDR report key: 7544261 · Received May 24, 2018

    Report

    Report Number
    MW5077449
    Event Type
    Injury
    Date Received
    May 24, 2018
    Date of Event
    September 7, 2017
    Report Date
    May 17, 2018
    Manufacturer
    EPIMED INTERNATIONAL INC.
    Product Code
    CAZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT HAD CATHETER PLACED FOR LOA PROCEDURE (B)(6) 2017. PT LEFT LSDC WITH CATHETER SECURED FOR INFUSION AT WATSON CLINIC NEXT DAY (B)(6) 2017. CATHETER REMOVED (B)(6) 2017 IN OFFICE. PER MD PT C/O BACK ISSUES SINCE REMOVAL. FB IDENTIFIED. DATES OF USE: (B)(6) 2017 - (B)(6) 2017. DIAGNOSIS OR REASON FOR USE: LOW BACK AND LEFT LEG PAIN. M. DEVICES GROUP, (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385941 EPIMED RADIOPAQUE EPIDURAL CATHETER CAZ EPIMED INTERNATIONAL INC. 11427899

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other