BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUT SURGICAL SUTURE

    MDR report key: 1003267 · Received February 27, 2008

    Report

    Report Number
    2210968-2008-00121
    Event Type
    Injury
    Date Received
    February 27, 2008
    Report Date
    January 30, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAL
    PMA / PMN Number
    N10369
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 SUTURE THAT HAD NOT ABSORBED AT AN UNSPECIFIED TIME FOLLOWING CONJUNCTIVAL SURGERY. THE PT UNDERWENT SURGICAL REMOVAL OF THE SUTURE. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUT SURGICAL SUTURE SUTURE, ABSORBABLE GAL ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention