BEUDAMED
    FDA Adverse Event Injury Summary report: N

    U.S.S.C. POLYSORB 1

    MDR report key: 271017 · Received March 24, 2000

    Report

    Report Number
    1219161-2000-00266
    Event Type
    Injury
    Date Received
    March 24, 2000
    Date of Event
    January 27, 2000
    Report Date
    February 25, 2000
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SUTURE WAS USED DURING A COLON RESECTION. REPORTEDLY, THE SUTURE BROKE. THE SURGEON PERFORMED A RE-OPERATION ON 2/22/2000 TO CORRECT THE CONDITION. THE HOSPITAL HAS REPORTED THE PT'S CONDITION IS SATISFACTORY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention