BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMIC GUT

    MDR report key: 2021834 · Received March 9, 2011

    Report

    Report Number
    2021834
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    January 17, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    GAL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A VASECTOMY IN 2010 A PATIENT KEPT RETURNING WITH EPIDIDYMITIS. ANTIBIOTICS WERE USED BUT STILL DID NOT COMPLETELY CLEAR THE PROBLEM. REPEAT SURGERY WAS PERFORMED EIGHT MONTHS LATER AND THE DOCTOR DISCOVERED REMNANTS OF THE ABSORBABLE CHROMIC SUTURE MATERIAL STILL AT THE SITE.MANUFACTURER RESPONSE FOR SUTURE, ABSORBABLE, CHROMIC GUT: MFG QA TOOK DOWN INFORMATION AS A PRODUCT INQUIRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHROMIC GUT SUTURE, ABSORBABLE GAL ETHICON, INC. G122H *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NONE KNOWN.