BEUDAMED
    FDA Adverse Event Other Summary report: N

    100-07

    MDR report key: 2034648 · Received March 17, 2011

    Report

    Report Number
    1056553-2011-00002
    Event Type
    Other
    Date Received
    March 17, 2011
    Date of Event
    February 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    REMINGTON MEDICAL, INC.
    Product Code
    DYB
    PMA / PMN Number
    K93237C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MFG EVAL IS IN PROCESS AND UPDATE TO FORM 3500A WILL BE SUBMITTED UPON COMPLETION OF EVAL.

    Description of Event or Problem · 1

    REMINGTON MEDICAL, INC SALES REP WAS CONTACTED BY (B)(6) MGR ON (B)(4) 2011 AND REPORTED THAT THE VALVE OF THE INTRODUCER BECAME DISPLACED WHEN THE DILATOR WAS REMOVED FROM THE SHEATH (PRIOR TO TEAR-AWAY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 100-07 SEAL-A-WAY INTRODUCER KIT DYB REMINGTON MEDICAL, INC. 100-07 102912

    Patients

    Seq Age Sex Outcome Treatment
    1 NA