BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHILON NYLON SUTURE

    MDR report key: 1092205 · Received August 1, 2008

    Report

    Report Number
    2210968-2008-00647
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    June 30, 2008
    Report Date
    July 2, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAR
    PMA / PMN Number
    N85316
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PT PRESENTED WITH AN INFECTION TWO WEEKS FOLLOWING ARTHROSCOPIC SURGERY. THE PT WAS PRESCRIBED AUGMENTIN. THE PT IS REPORTED AS RESOLVED/HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHILON NYLON SUTURE SUTURE, NON-ABSORBABLE GAR ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention