BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUT SURGICAL SUTURE

    MDR report key: 2190442 · Received July 28, 2011

    Report

    Report Number
    2210968-2011-01014
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    March 9, 2011
    Report Date
    June 30, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    GAL
    PMA / PMN Number
    N10389
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): CONCLUSIONS: 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 A PATIENT UNDERWENT A SEPTOPLASTY PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED. ON (B)(6) 2011, THE PATIENT EXPERIENCED AN EVOLUTION OF A CURVATURE IN THE CAUDAL SEPTAL REGION WITH FORMATION OF GRANULOMA WHERE THE SUTURE WAS PLACED. A SEPTAL ABSCESS ALSO WAS OBSERVED. THE PATIENT UNDERWENT DRAINAGE PROCEDURE AT THE HOSPITAL AND THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS TO CURE THE PROBLEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R