BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPILONG SOFT

    MDR report key: 8415334 · Received March 13, 2019

    Report

    Report Number
    9611612-2019-00006
    Event Type
    Injury
    Date Received
    March 13, 2019
    Date of Event
    February 5, 2019
    Report Date
    April 11, 2019
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    CAZ
    UDI-DI
    14048223013134
    PMA / PMN Number
    K060311
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON RISK ASSESSMENT AND CLINICAL EVALUATION REPORT AS WELL AS SUBSTANTIATED BY POST MARKET DATA THIS CASE IS CONSIDERED AS CLOSED.

    Description of Event or Problem · 0

    IRN#: (B)(4). TENTATIVE SUMMARIZING TRANSLATION FROM INITIAL REPORTER´S NARRATIVE: PT UNDERWENT UNEVENTFUL IVOR LEWIS MINIMAL INVASIVE ESOPHAGECTOMY. ANALGESIA WAS ADMINISTERED THROUGH A THORACOSCOPIC PLACED PARAVERTEBRAL CATHETER PLACED BY THE SURGEON DURING THE OPERATION, WITH GOOD EFFECT. AFTER REMOVAL OF CATHETER, 5 DAYS POST OPERATION, THE NURSE NOTICED THE END OF THE CATHETER WAS DESTRUCTED.

    Additional Manufacturer Narrative · 1

    EVENT TOOK PLACE IN (B)(6) AND HAS BEEN REPORTED THROUGH DISTRIBUTION SUBSIDIARY PAJUNK MEDICAL PRODUKTE GMBH. CURRENTLY THE DATA IS POOR AND THE DEVICE HAS NOT BEEN RETURNED/ ANALYSED. AS SOON AS FURTHER DATA WILL BE AVAILABLE A FOLLOW UP REPORT WILL BE SENT IN TO THE AGENCY.

    Description of Event or Problem · 1

    (B)(4). TENTATIVE SUMMARIZING TRANSLATION FROM INITIAL REPORTER´S NARRATIVE: PT UNDERWENT UNEVENTFUL IVOR LEWIS MINIMAL INVASIVE ESOPHAGECTOMY. ANALGESIA WAS ADMINISTERED THROUGH A THORACOSCOPIC PLACED PARAVERTEBRAL CATHETER PLACED BY THE SURGEON DURING THE OPERATION, WITH GOOD EFFECT. AFTER REMOVAL OF CATHETER, 5 DAYS POST OPERATION, THE NURSE NOTICED THE END OF THE CATHETER WAS DESTRUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210072 EPILONG SOFT CATHETER, ANAESTHESIA CONDUCTION, EPIDURAL, CONTINUOUS CAZ PAJUNK GMBH MEDIZINTECHNOLOGIE 0431157-51 1256 14048223013134

    Patients

    Seq Age Sex Outcome Treatment
    1 Other