MalfunctionIWI
I-125 SEED
Received Oct 21, 1997 · Event occurred Sep 23, 1997
Report 1416947-1997-03870 · MDR key 130007
Patient
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Narrative
Description of Event or Problem
I-125 SEEDS WITH APPROXIMATE ACTIVITY OF 0.34MCI/SEED WERE ASSAYED INCORRECTLY PRIOR TO SHIPMENT AND WERE INCORRECTLY LABELED AS 0.28-0.30MCI/SEED (LOT #W71536). ALSO, LABEL SHOWED ASSAY DATE OF 22 AUG 97 AND SHOULD HAVE BEEN 22 SEPT 97. ONLY ONE SEED PERMANENTLY IMPLANTED IN PT IS CONFIRMED AS BEING AT THE HIGHER ACTIVITY. ALL OTHER SEEDS FROM THIS LOT ARE ACCOUNTED FOR.