BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALTRAC BOWEL ANASTOMOTIC RING 28MM/1.5MM

    MDR report key: 343913 · Received July 24, 2001

    Report

    Report Number
    2647580-2001-00392
    Event Type
    Malfunction
    Date Received
    July 24, 2001
    Date of Event
    June 19, 2001
    Report Date
    June 25, 2001
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    LNN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, WHEN THE SURGEON INSERTED THE DEVICE INTO THE INTESTINE, IT CRACKED. THE ANASTOMOSIS WAS HAND SEWED. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33290 VALTRAC BOWEL ANASTOMOTIC RING 28MM/1.5MM ANASTOMOSIS RINGS LNN UNITED STATES SURGICAL CORP. NA 897467

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN