BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II (POLYDIOXANONE) SUTURE

    MDR report key: 166463 · Received May 8, 1998

    Report

    Report Number
    2210968-1998-00165
    Event Type
    Injury
    Date Received
    May 8, 1998
    Date of Event
    November 11, 1997
    Report Date
    April 9, 1998
    Manufacturer
    ETHICON, INC.
    Product Code
    GAN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    SUTURE BREAKAGE POST OP- RECEIVED VIA MEDWATCH REPORT #1013144 ON DATE 4/9/98. STATED A 69 YEAR OLD FEMALE WAS ADMITTED FOR AN EXPLORATORY LAP. SEVEN DAYS POST-OP, 11/11/97, THE WOUND DEHISCED. THE PT WAS TAKEN BACK TO SURGERY FOR REPAIR OF THE WOUND DEHISCENCE. IT WAS NOTED SUTURE BROKE. SUTURE PDS SIZE 1 WAS USED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention