BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 811603 · Received February 1, 2007

    Report

    Report Number
    2210968-2007-00116
    Event Type
    Injury
    Date Received
    February 1, 2007
    Date of Event
    September 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

    CUSTOMER REPORTS EXPERIENCING CONTINUED PAIN FOLLOWING DEVICE IMPLANT IN 2005. THE PATIENT WAS SEEN BY HER GYNECOLOGIST ON MULTIPLE OCCASIONS. THE PHYSICIAN EXCISED A PORTION OF THE INITIAL WOUND INCISION, CLEANSED AND RECLOSED THE SITE.

    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