BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USSC SURGIPRO 0

    MDR report key: 76717 · Received March 12, 1997

    Report

    Report Number
    1219161-1997-00271
    Event Type
    Malfunction
    Date Received
    March 12, 1997
    Date of Event
    February 12, 1997
    Report Date
    February 12, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE COULD NOT CONFIRM THAT THE SUTURE STRAND WAS BROKEN HOWEVER, FRAYING WAS OBSERVED.

    Description of Event or Problem · 1

    DURING A COLON RESECTION PROCEDURE, THE SUTURE BROKE. THE SURGEON APPLIED ANOTHER DEVICE WITHOUT PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 USSC SURGIPRO 0 Implant POLYPROPYLENE SUTURE GAW UNITED STATES SURGICAL CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN