BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PANACRYL (L-LACTIDE/GLYCOLIDE) SUTURE

    MDR report key: 294819 · Received September 8, 2000

    Report

    Report Number
    2210968-2000-00356
    Event Type
    Injury
    Date Received
    September 8, 2000
    Report Date
    August 15, 2000
    Manufacturer
    ETHICON, INC.
    Product Code
    GAN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT EXPERIENCED A SINUS FORMATION AND SUTURE EXTRUSION FOLLOWING A LAPAROTOMY PROCEDURE. THE PT IS EXPERIENCING CHRONIC NON-HEALING WOUNDS. THE SURGEON IS PLANNING TO REMOVE THE SUTURE SURGICALLY AND TO RE-DO THE SUTURE LINE USING ANOTHER SUTURE TYPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PANACRYL (L-LACTIDE/GLYCOLIDE) SUTURE SUTURE, ABSORBABLE GAN ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention