BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910)SUTURE

    MDR report key: 704016 · Received April 25, 2006

    Report

    Report Number
    2210968-2006-00319
    Event Type
    Injury
    Date Received
    April 25, 2006
    Date of Event
    February 15, 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

    H-6 CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. K946271.

    Description of Event or Problem · 1

    THE PT PRESENTED WITH BLEEDING SEVEN DAYS FOLLOWING HEMORROIDECTOMY. IT WAS REPORTED THAT THE SUTURE BROKE. 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 Hospitalization