BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL PLUS ANTIBACTERIAL SUTURE

    MDR report key: 702103 · Received April 20, 2006

    Report

    Report Number
    2210968-2006-00305
    Event Type
    Injury
    Date Received
    April 20, 2006
    Report Date
    March 21, 2006
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. 510(K)# K022715.

    Description of Event or Problem · 1

    A PATIENT PRESENTED WITH A SEROMA AT AN UNSPECIFIED TIME FOLLOWING SURGERY. THE PATIENT WAS RETURNED TO SURGERY FOR EXCISION OF THE SEROMA. NO FURTHER DETAILS WERE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention