BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDINAL

    MDR report key: 2163550 · Received July 7, 2011

    Report

    Report Number
    MW5021311
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 16, 2011
    Report Date
    July 7, 2011
    Manufacturer
    MEDICAL PRODUCTS & SERVICES
    Product Code
    KDD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING A PACEMAKER IMPLANTED. DURING COUNT IT WAS NOTED RAYTEX WAS MISSING. X-RAY OBTAINED. RAYTEX DID NOT SHOW ON X-RAY. PHYSICIAN REOPENED INCISION AND LOCATED RAYTEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDINAL STR MAJOR SURGICAL SETUP KIT KDD MEDICAL PRODUCTS & SERVICES

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention