BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHEMO-PORT

    MDR report key: 964905 · Received August 15, 2006

    Report

    Report Number
    2925153-2006-00029
    Event Type
    Other
    Date Received
    August 15, 2006
    Report Date
    August 15, 2006
    Manufacturer
    HDC CORP.
    Product Code
    LJT
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT NEVER REPORTED THE EVENT TO HDC CORPORATION. THUS, BASED ON INSUFFICIENT INFO ON THE MEDWATCH VOLUNTARY REPORT HDC FILED THIS EVENT AS MDR REPORT. UPON RECEIVING A COPY OF FDA MEDWATCH VOLUNTARY REPORT, HDC HAD MADE SEVERAL ATTEMPTS TO COLLECT MORE INFO ON THE INCIDENT AND THE PRODUCT AND LOT NUMBER. UNFORTUNATELY, RN. STATED THAT SHE COULD NOT RECALL THE INCIDENT. SO, RN HAD REFERRED HDC TO THE MEDICAL RECORDS DEPT . THE RECORD DEPT SAID THAT THEY COULD NOT HELP WITHOUT PT INFO. THE RECORD DEPT REFERRED HDC TO THE RISK MGR. HDC LEFT THREE MESSAGES TO THE RISK MGR VOICE MAIL. UP TO DATE NO RESPONSE FROM THE INSTITUTION WHICH HAD FILED A VOLUNTARY MEDWATCH REPORT WITH INSUFFICIENT INFO TO UNDERSTAND THE CASE. NO SAMPLE AVAILABLE TO VERIFY OR UNDERSTAND THE EVENT DESCRIBED ON SECTION 5 TO PAGE 1. HDC WILL NOT BE ABLE TO PERFORM AN INVESTIGATION BECAUSE NO PRODUCT NUMBER OR LOT NUMBER WERE PROVIDED. HDC CAPTURED THIS EVENT IN THE COMPLAINT TRENDING DATABASE.

    Description of Event or Problem · 1

    "PAC WAS TRANSECTED AT HUB."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHEMO-PORT ACCESS DEVICE LJT HDC CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN