BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERASEED PD-103 IMPLANTS

    MDR report key: 342249 · Received July 12, 2001

    Report

    Report Number
    1037598-2001-00002
    Event Type
    Other
    Date Received
    July 12, 2001
    Date of Event
    June 19, 2001
    Report Date
    July 12, 2001
    Manufacturer
    THERAGENICS CORP.
    Product Code
    IWG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN ASSOCIATE OF THE HOSPITAL'S HEALTH PHYSICIST PLACED A PROSTATE BRACHYTHERAPY ORDER FOR 1.4 MCI, AND THE ORDER WAS ENTERED USING MANUFACTURER'S STANDARD PROCEDURES AS 1.4 MCI AAPP,T97 (BASED ON THE CD-109 STANDARD). THE HOSPITAL'S HEALTH PHYSICIST INTENDED A PRESCRIPTION OF 1.8 U SK, N99 (BASED ON THE NIST 1999 WAFAC STANDARD), WHICH CORRESPONDED TO 1.1 MCI AAPP,T97 RATHER THAN 1.4 MCI AAPP, T97. USER RECEIVED A FAX CONFIRMATION 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 1.36 MCI AAPP, T97, EQUIVALENT TO 2.19 U SK, N99, RATHER THAN THE PLANNED 1.8 U SK, N99, RESULTING IN A 21% MISADMINISTRATION (HIGHER ACTIVITY THAN PRESCRIBED). THERAGENICS WAS NOTIFIED OF THE EVENT BY THE USER THE NEXT DAY. THE PATIENT HAS NOT EXPERIENCED IMPAIRMENT OR DAMAGE FROM THIS MISADMINISTRATION. THE HEALTH PHYSICIST HAS STATED THAT HE DOES NOT ANTICIPATE FUTURE COMPLICATIONS. A SIX-WEEK CHECK-UP IS SCHEDULED FOR PATIENT EVALUATION, AND THE MANUFACTURER WILL RE-CONTACT THE HOSPITAL TO DETERMINE PATIENT'S STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31696 THERASEED PD-103 IMPLANTS BRACHYTHERAPY IMPLANTS IWG THERAGENICS CORP. MODEL 200 0123H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other