BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 697157 · Received April 7, 2006

    Report

    Report Number
    2210968-2006-00279
    Event Type
    Injury
    Date Received
    April 7, 2006
    Date of Event
    February 12, 2006
    Report Date
    March 10, 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

    CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIAPTED. NDA# N18176

    Description of Event or Problem · 1

    A PT PRESENTED WITH A REPORT OF A BROKEN SUTURE TWO DAYS FOLLOWING PERINEAL REPAIR. THE PT WAS SEEN AT ANOTHER FACILITY AND THE WOUND 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 UH2658

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention