BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U.S.S.C. POLYSORB 0

    MDR report key: 150524 · Received February 19, 1998

    Report

    Report Number
    1219930-1998-00177
    Event Type
    Malfunction
    Date Received
    February 19, 1998
    Date of Event
    January 1, 1998
    Report Date
    January 23, 1998
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE SUTURE BROKE. THE SURGEON USED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U.S.S.C. POLYSORB 0 Implant SYNTHETIC ABSORBABLE SUTURE GAN UNITED STATES SURGICAL CORP. NA A7H123HN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN