THERASEED MODEL 200 TS200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-06-05 for THERASEED MODEL 200 TS200 manufactured by Theragenics Corp.

Event Text Entries

[126380] Two shipments were rec'd by the user facility, each having a different lot number. Shipment a contained the calibration seed for shipment b and shipment b contained the calibration seed for shipment a. The user facility detected the error and there was no pt impact.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1057128-1999-00001
MDR Report Key229664
Report Source05
Date Received1999-06-05
Date of Report1999-06-04
Date of Event1999-04-13
Date Mfgr Received1999-05-07
Device Manufacturer Date1999-04-01
Date Added to Maude1999-07-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTHERASEED
Generic NameBRACHYTHERAPY IMPLANT
Product CodeIWG
Date Received1999-06-05
Model NumberMODEL 200
Catalog NumberTS200
Lot Number9914F & 9914G
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeUNKNOWN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedU
Device Sequence No1
Device Event Key222735
ManufacturerTHERAGENICS CORP
Manufacturer Address5203 BRISTOL INDUSTRIAL WAY BUFORD GA 30518 US
Baseline Brand NameTHERASEED
Baseline Generic NameRADIONUCLIDE BRACHYTHERAPY SOURCE
Baseline Model NoMODEL 200
Baseline Catalog NoTS200
Baseline IDNA
Baseline Device FamilyRADIONUCLIDE BRACHYTHERAPY SOURCE
Baseline Shelf Life Contained*
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK874787
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 1999-06-05

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