THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "WARNINGS AND PRECAUTIONS":INITIATE RADIATION SURVEYS ON ALL COMPONENTS UPON COMPLETION OF THE SEED IMPLANT. WARNING: NEVER IMPLANT VISIBLY DAMAGED BRACHY SOURCE SEED IMPLANTS" DESCRIBES HOW TO HANDLE THE SEEDS AND WHAT WILL OCCUR SHOULD SUCH FORCE DAMAGE THE SOURCE." (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE WAS NOT RETURNED.
D
Patient 1
IT WAS REPORTED THAT DURING THE REVIEW OF A X-RAY TAKEN ON (B)(6), ONE OF THE SEEDS PLACED IN THE PATIENT ON (B)(6), APPEARED TO BE BROKEN. THE FACILITY STATED THAT THEY DID NOT ENCOUNTER ANY PROBLEMS WHILE OPERATING THE LOADER AND INSERTING THE SEEDS. THE ANALYSIS OF THE EQUIPMENT, THE IRRIGATION WATER, AND THE ANTIMONY VESSEL USED AFTER THE PROCEDURE; DID NOT SHOW ANY PROBLEMS. THE PATIENT'S URINE WAS TESTED THE FOLLOWING DAY AND DID NOT INDICATE ANY PROBLEMS.