BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON VICRYL SUTURE

    MDR report key: 28536 · Received November 2, 1995

    Report

    Report Number
    28536
    Event Type
    Injury
    Date Received
    November 2, 1995
    Report Date
    October 30, 1995
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS RE-ADMITTED ON 9/21 WITH A SUPERFICIAL WOUND INFECTION AT SURGERY SITE (SURGERY DATE 8/30/95). INFECTION ATTRIBUTED TO "SUTURE FAILURE AND/OR REJECTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON VICRYL SUTURE SUTURE MATERIAL GAM ETHICON, INC. EE9925 DM9948

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization