BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERASEED PALLADIUM 103 IMPLANTS

    MDR report key: 330384 · Received May 4, 2001

    Report

    Report Number
    1037598-2001-00001
    Event Type
    Other
    Date Received
    May 4, 2001
    Date of Event
    February 26, 2001
    Report Date
    May 2, 2001
    Manufacturer
    THERAGENICS CORP
    Product Code
    IWG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DISTRIBUTOR MIS-KEYED THE PRESCRIBED ACTIVITY FOR THIS PROSTATE BRACHYTHERAPY ORDER, SPECIFYING 1.28 U SK,N99 (BASED ON THE NIST 1999 WAFAC STANDARD), WHEN THE USER REQUESTED 1.28 MCI AAPP,T97 (BASED ON THE CD-109 STANDARD). MFR FILLED THE ORDER AS 1.28 U SK,N99. DISTRIBUTOR AND USER RECEIVED FAX CONFIRMATIONS OF THE ORDER PRIOR TO SHIPMENT, BUT DID NOT DETECT THE ACTIVITY DISCREPANCY. USER'S RECEIVING PROCEDURES FOR THE INCOMING ORDER ALSO DID NOT REVEAL THE ACTIVITY DISCREPANCY. THE ORDER WAS IMPLANTED IN 2001 AT AN ACTIVITY OF 0.74 MCI AAPP,T97 RATHER THAN THE PLANNED 1.28 MCI AAPP,T97, RESULTING IN A 41% MISADMINISTRATION (LOWER ACTIVITY THAN PRESCRIBED). THERAGENICS WAS NOTIFIED OF THE EVENT BY THE USER IN 4/2001. THE PT HAS NOT, AND WILL NOT, EXPERIENCE PERMANENT IMPAIRMENT OR DAMAGE FROM THIS MISADMINISTRATION. THE MISADMINISTRATION IS BEING REPORTED AS A MDR ADVERSE EVENT, BECAUSE THE DOSE DELIVERED WAS LIKELY NOT HIGH ENOUGH TO BE EFFICACIOUS FOR THE INTENDED TREATMENT OF PROSTATE CANCER, AND FOLLOW-UP THERAPY WILL POTENTIALLY BE REQUIRED TO COMPLETE THE PT'S TOTAL TREATMENT. THERAGENICS HAS REFERRED THE USER FOR CONSULTATION TO AN ONCOLOGIST EXPERIENCE IN PERFORMING EXTERNAL BEAM BOOST TREATMENTS FOLLOWING PROSTATE SEED IMPLANTS. THE DEVICE ORDER WAS IMPLANTED AND, THEREFORE, NOT RETURNED FOR CORRECTION. NO OTHER PTS OR ORDERS HAVE BEEN, NOR WILL BE, AFFECTED BY THIS ACTIVITY DISCREPANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20699 THERASEED PALLADIUM 103 IMPLANTS BRACHYTHERAPY IMPLANTS IWG THERAGENICS CORP MODEL 200 0107F

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other