BEUDAMED
    FDA Adverse Event Other Summary report: N

    T A PACK (TNCHQ)624

    MDR report key: 870847 · Received May 16, 2007

    Report

    Report Number
    1423507-2007-00057
    Event Type
    Other
    Date Received
    May 16, 2007
    Date of Event
    February 28, 2007
    Report Date
    May 16, 2007
    Manufacturer
    CARDINAL HEALTH
    Product Code
    LRP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A & E MEDICAL, MANUFACTURERS OF THE COMPONENT, HAVE DECLINED TO FILE AN MDR. CARDINAL HEALTH IS FILING AS THE CONVENIENCE KIT PACKAGER. PER A&E: WITHOUT AN EXAMINATION OF THE INVOLVED DEVICE, IT IS IMPOSSIBLE TO DETERMINE WHETHER OR NOT THE DEVICE IS A CONTRIBUTORY FACTOR IN THE INCIDENT. REVIEW OF DOCUMENTATION FOR THE INDICATED LOT FINDS ALL MATERIAL, PROCESS AND INSPECTION RECORDS TO BE ACCEPTABLE WITH NO EVIDENCE OF POTENTIAL PRODUCT PERFORMANCE ISSUES. CARDINAL HEALTH HAS PERFORMED A DESIGN REVIEW OF THIS PACK AND NO POTENTIAL DESIGN CONCERNS APPEAR TO BE RELATED TO THIS COMPONENT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T A PACK (TNCHQ)624 T A PACK LRP CARDINAL HEALTH SEN36TNCHQ 741310

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR