BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDCOMP

    MDR report key: 2820987 · Received October 30, 2012

    Report

    Report Number
    MW5027453
    Event Type
    Injury
    Date Received
    October 30, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 30, 2012
    Manufacturer
    MEDICAL COMPONENTS, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TEARAWAY INTRODUCER FLAPS/WINGS DETACHED FROM SHEATH. UNABLE TO RETRIEVE SHEATH PORTION FROM PT¿S ARM WITHOUT SURGICAL INTERVENTION. DATE OF USE: (B)(6) 2012. REASON FOR USE: AMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDCOMP TEARAWAY INTRODUCER, 5FR X 6CM DYB MEDICAL COMPONENTS, INC. MBLS270

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention