BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II (POLYDIOXANONE) SUTURE

    MDR report key: 568603 · Received January 28, 2005

    Report

    Report Number
    2210968-2005-00041
    Event Type
    Injury
    Date Received
    January 28, 2005
    Report Date
    January 3, 2005
    Manufacturer
    ETHICON, INC.
    Product Code
    GNH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SUTURE BROKE AT AN UNSPECIFIED TIME FOLLOWING SURGERY. PT WAS TAKEN TO THE O.R. FOR SURGICAL REPAIR. NO FURTHER INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PDS II (POLYDIOXANONE) SUTURE SUTURE, ABSORBABLE GNH ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention