BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7 FR. PTFE INTRODUCER KIT

    MDR report key: 890127 · Received August 3, 2007

    Report

    Report Number
    1720496-2007-00158
    Event Type
    Injury
    Date Received
    August 3, 2007
    Date of Event
    June 28, 2007
    Report Date
    July 2, 2007
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    DYB
    PMA / PMN Number
    K860432
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVALUATION AT THIS TIME. A CHR REVIEW SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT FILE(S) FROM THIS LOT. 132475.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END OF THE INTRODUCER 'CURLED UP' AND RIPPED THE VEIN. THE SURGEON HAD TO CUT DOWN AND SEW UP THE VESSEL STOPPING THE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7 FR. PTFE INTRODUCER KIT DYB C.R. BARD, INC. (BASD) RERC0166

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention