BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 811583 · Received February 1, 2007

    Report

    Report Number
    2210968-2007-00117
    Event Type
    Injury
    Date Received
    February 1, 2007
    Date of Event
    January 1, 2005
    Report Date
    January 2, 2007
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    k946271
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF SEVEN MEDWATCH REPORTS BEING SUBMITTED AS SEVEN SEPARATE DEVICES/EVENTS WERE REPORTED. SEE 2210968-2007-00002, 2210968-2007-00114, 2210968-2007-00115, 2210968-2007-00116, 2210968-2007-00117, 2210968-2007-00118, AND 2110968-2007-00119 FOR THE OTHER MEDWATCH REPORTS. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    PATIENT REPORTS PRESENTING FOR A LOCAL ULCERATION. THE SURGEON REPORTEDLY CLEANED AND RECLOSED THE ULCERATED SITE. THE PATIENT SUBSEQUENTLY DEVELOPED AN ADDITIONAL ULCER. THE SITE WAS EXCISED AND RECLOSED. THIS EVENT OCCURRED THREE TIMES BETWEEN 2005 AND 2006. THIS REPORT REPRESENTS THE FIRST OF THREE EVENTS.

    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 YR Required Intervention