BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUT SURGICAL SUTURE

    MDR report key: 1910367 · Received November 24, 2010

    Report

    Report Number
    2210968-2010-01599
    Event Type
    Injury
    Date Received
    November 24, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAL
    PMA / PMN Number
    N10389
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A CESAREAN SECTION PROCEDURE ON AN UNK DATE AND SUTURE WAS USED. THE PT DEVELOPED INTERNAL HEMORRHAGING AFTER THE PROCEDURE AND WAS TREATED WITH A TRANSFUSION. IT IS UNK IF THE HEMORRHAGE WAS CAUSED BY PITOCIN OR THE SUTURE. AFTER THE TRANSFUSION, THE PT WAS "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUT SURGICAL SUTURE SUTURE, ABSORBABLE GAL ETHICON, INC. NA CH6193

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention