THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND WITH APPLICABLE LAWS AND REGULATIONS. INDICATIONS: FOR PLACEMENT OF RADIOACTIVE SEEDS IN TRANSPERINEAL IMPLANT PROCEDURES. CAUTION: USING THE STYLET WITH EXCESSIVE FORCE TO MANIPULATE LODGED SEEDS MAY DAMAGE THE SEED. CAUTION: NEEDLES ARE NOT INTENDED TO PENETRATE BONE. IF RESISTANCE IS ENCOUNTERED, VERIFY NEEDLE POSITION. DO NOT PUSH INTO BONE; THIS MAY CAUSE NEEDLE TO BEND OR BREAK. REPLACE NEEDLE IF CANNULA, OR POINT, IS DAMAGED." (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 THERE WERE ONLY FOUR NEEDLES INSTEAD OF FIVE NEEDLES IN THE POUCH. THE PROCEDURE WAS PERFORMED WITH FOUR NEEDLES AND ALL SEEDS WERE IMPLANTED INTO THE PATIENT. THE PATIENT RECEIVED THE INTENDED DOSAGE.
N
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. CORRECTIONS: EVALUATION CODS, ADDITIONAL MFR NARRATIVE. 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 THERE WERE ONLY FOUR NEEDLES INSTEAD OF FIVE NEEDLES IN THE POUCH. THE PROCEDURE WAS PERFORMED WITH FOUR NEEDLES AND ALL SEEDS WERE IMPLANTED INTO THE PATIENT. THE PATIENT RECEIVED THE INTENDED DOSAGE.
N
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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 THERE WERE ONLY FOUR NEEDLES INSTEAD OF FIVE NEEDLES IN THE POUCH. THE PROCEDURE WAS PERFORMED WITH FOUR NEEDLES AND ALL SEEDS WERE IMPLANTED INTO THE PATIENT. THE PATIENT RECEIVED THE INTENDED DOSAGE.