BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFLEX ESOPHAGEAL STENT

    MDR report key: 726909 · Received June 20, 2006

    Report

    Report Number
    6000146-2006-00002
    Event Type
    Injury
    Date Received
    June 20, 2006
    Report Date
    May 31, 2006
    Manufacturer
    RUSCH GMBH GERMANY/TELEFLEX MEDICAL
    Product Code
    ESW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE

    Narratives

    Additional Manufacturer Narrative · 1

    D4 - USER FACILITY WAS UNABLE TO SUPPLY THE CORRECT LOT NUMBER OF THE DEVICE USED; CONSEQUENTLY THE EXPIRATION DATE OF THE DEVICE IS UNKNOWN. D11 - UNKNOWN/NO INFORMATION AVAILABLE FROM USER FACILITY. PT CODES - 2249 - MIGRATION/LABELED, 2365 REMOVAL OF FOREIGN BODY/NOT LABELED. DEVICE CODES - 1395 - MIGRATION/LABELED. INFORMATION SUPPLIED IN SECTION F WAS COMPLETED BY THE MANUFACTURER BASED ON INFORMATION OBTAINED FROM THE USER FACILITY. ANY INFORMATION NOT INCLUDED IN THIS SECTION OR ANY OTHER SECTION WAS NA AT THE TIME OF SUBMISSION OF THIS MEDWATCH REPORT TO THE FDA. H4 - USER FACILITY WAS UNABLE TO SUPPLY THE CORRECT LOT NUMBER OF THE DEVICE USED, CONSEQUENTLY, THE MANUFACTURE DATE OF THE DEVICE IS UNKNOWN. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE IF THE DEVICE MET SPECIFICATION. SHOULD FURTHER RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED UNDER THE APPROPRIATE SEQUENCE NUMBER. WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT AT THIS TIME. OUR DIRECTIONS FOR USE OUTLINE APPROPRIATE PLACEMENT, ACCESS AND MAINTENANCE PROCEDURES. BSC REFERENCE # TW135895 / A00025135, DATE FILED: 20 JUNE 2006.

    Description of Event or Problem · 1

    THE COMPLAINANT HAS REPORTED THAT A CHILD SUSTAINED AN ESOPHAGEAL ALKALI BURN AS A RESULT OF ACCIDENTAL INGESTION OF A LYE SOLUTION. THE PATIENT HAD THERAPEUTIC PLACEMENT OF A POLYFLEX ESOPHAGEAL STENT IN 2005. THE EVENT INFORMATION STATES THAT "9 MONTHS LATER" THE STENT MIGRATED INTO THE STOMACH. THE MIGRATED STENT WAS REMOVED WITHOUT ISSUE. ANOTHER POLYFLEX STENT WAS PLACED SUCCESSFULLY WITHOUT ISSUE. PLEASE NOTE ASSOCIATED MEDWATCH REPORT 6000146-2006-00003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFLEX ESOPHAGEAL STENT ESOPHAGEAL PROSTHESIS ESW RUSCH GMBH GERMANY/TELEFLEX MEDICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention