BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUT CHROMIC SUTURE

    MDR report key: 3813042 · Received May 15, 2014

    Report

    Report Number
    2210968-2014-06148
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 25, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAL
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SEPTOPLASTY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS NOT ABSORBING AND THE PATIENT EXPERIENCED SEVERE INFLAMMATION. SUTURE WAS REMOVED BY THE SURGEON. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290855 GUT CHROMIC SUTURE SUTURE, ABSORBABLE GAL ETHICON INC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention