BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 709046 · Received May 5, 2006

    Report

    Report Number
    2210968-2006-00345
    Event Type
    Injury
    Date Received
    May 5, 2006
    Date of Event
    November 8, 2005
    Report Date
    April 5, 2006
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    K946271.

    Description of Event or Problem · 1

    A PATIENT PRESENTED WITH AN INFECTION AND SPLITTING FOLLOWING SKIN CANCER PROCEDURE ON THE RIGHT ARM. THE SITE WAS DEBRIDED AND ANTIBIOTIC THERAPY INITIATED. THE PATIENT HAD CONTINUED TO PURULENT DRAINAGE ONE WEEK FOLLOWING ONSET OF EVENT. THE PATIENT HAD RE-EXCISION OF THE INFECTED AREA ON 04/2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE , ABSORBABLE GAM ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention