BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 703931 · Received April 25, 2006

    Report

    Report Number
    2210968-2006-00317
    Event Type
    Injury
    Date Received
    April 25, 2006
    Date of Event
    February 13, 2006
    Report Date
    March 31, 2006
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AT THIS TIME. K946271.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTED THAT THE PT PRESENTED WITH BLEEDING NINE DAYS FOLLOWING HERMORRIOIDECTOMY. IT WAS RPEORTED THAT THE SUTURE WAS BROKEN. THE PT WAS RESUTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA ULZ406

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention