BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 708532 · Received May 3, 2006

    Report

    Report Number
    2210968-2006-00340
    Event Type
    Injury
    Date Received
    May 3, 2006
    Date of Event
    October 7, 2005
    Report Date
    April 5, 2006
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    H6: NO CONCLUSION CAN BE DRAWN AT THIS TIME. K946271.

    Description of Event or Problem · 1

    A PT PRESENTED WITH AN INFECTION 17 DAYS FOLLOWING A SKIN CANCER PRODUCED ON THEIR RIGHT SHOULDER. THE SITE WAS DEBRIDED AND THE PT WAS ADMINISTERED ANTIBIOTIC THERAPY.

    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 78 YR Required Intervention