BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SUTURE PRODUCT

    MDR report key: 328875 · Received April 26, 2001

    Report

    Report Number
    2210968-2001-00193
    Event Type
    Injury
    Date Received
    April 26, 2001
    Date of Event
    February 1, 2001
    Report Date
    March 29, 2001
    Manufacturer
    ETHICON, INC SOMERVILLE
    Product Code
    GAO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFECTION OCCURRED WITH A PT. THIS HAPPENED IN LATE FEBRUARY. THE INFECTION HAS PROMPTED THREE SEPARATE ADDITIONAL OPERATIONS. THE INITIAL OPERATION WAS AN ORTHOPAEDIC PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19224 UNK SUTURE PRODUCT UNK GAO ETHICON, INC SOMERVILLE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention