BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL PLUS ANTIBACTERIAL SUTURE

    MDR report key: 1369783 · Received April 24, 2009

    Report

    Report Number
    2210968-2009-00473
    Event Type
    Injury
    Date Received
    April 24, 2009
    Date of Event
    March 12, 2009
    Report Date
    March 27, 2009
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K022715
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 04/24/2009. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE PT PRESENTED WITH REDNESS AND SWELLING TWO WEEKS FOLLOWING AN ANTERIOR CERVICAL DISKECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VICRYL PLUS ANTIBACTERIAL SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other