BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEEL-AWY INTRO KIT 10F 14CM

    MDR report key: 263464 · Received February 18, 2000

    Report

    Report Number
    2182269-2000-00011
    Event Type
    Injury
    Date Received
    February 18, 2000
    Date of Event
    December 10, 1999
    Report Date
    February 18, 2000
    Manufacturer
    DAIG CORP.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SECTION OF THE DISTAL PORTION OF A 10F PEEL AWAY SHEATH SEPARATED, ENTERING THE PT. A FOUR INCH SECTION OF SHEATH WAS SUCCESSFULLY REMOVED. THE STATUS OF THE PT IS UNK. AS OF 02/17/2000, THERE HAS BEEN NO FURHER INFO PROVIDED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEEL-AWY INTRO KIT 10F 14CM PEEL-AWAY INTRO KIT, 10F DYB DAIG CORP. 405120 99CR04

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention