MAUDE Adverse Event Report | 合法醫療器材資訊網

Thehydromarkbreastbiopsysitemarkerisusedtomarktissueduringapercutaneousbreastbiopsyprocedure,bevisibleunderultrasoundforatleast6weeks, ...

The hydromark breast biopsy site marker is used to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and mri.It was reported that after an ultrasound biopsy with a hydromark marker, product code 4010-02-15-t3, caused a reaction in the patient.The patient experienced redness and pain to the breast.No testing on the specific device has been conducted as the device was not returned for evaluation.However, sensitivity, cytoxicity and other reaction testing was conducted as part of the initial qualification of this device.No known reactions similar to those reported in this event were reported during this testing.Although it could not be concluded that our device caused or contributed to this event, due to the ...