BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 1222104 · Received November 5, 2008

    Report

    Report Number
    2210968-2008-01094
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    September 29, 2008
    Report Date
    October 10, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAW
    PMA / PMN Number
    N16374
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 11/05/2008. CONCLUSION: NO CONCLUSION CAN BE MADE. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL 3500 A FORM WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PATIENT DEVELOPED SWELLING IN THE NECK REGION WITH BLOOD FILLING THE RESERVOIR SHORTLY AFTER A CAROTID ENDARTERECTOMY PROCEDURE. THE PATIENT WAS RETUNED TO SURGERY. THE SURGEON REPORTED THAT THE RUNNING SUTURE LINE WAS BROKEN. THE PATIENT WAS RESUTURED AND IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE POLYPROPYLENE SUTURE SUTURE, NON-ABSORBABLE GAW ETHICON, INC. NA AEE046

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention