BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 520664 · Received April 14, 2004

    Report

    Report Number
    2210968-2004-00204
    Event Type
    Injury
    Date Received
    April 14, 2004
    Date of Event
    February 1, 2004
    Report Date
    March 17, 2004
    Manufacturer
    ETHICON, INC. SAN ANGELO
    Product Code
    GAM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE STATES THAT HOSPITAL REPORTS FOLLOWING SURGICAL PROCEDURE, USING A HORIZONTAL MATTRESS SUTURING TECHNIQUE, THE DEVICE BROKE 3 DAYS POST-OP. RE-OPERATION PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention