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 reported adverse event this has been determined to be reportable pursuant to 21 cfr 803.As such, we are submitting this medwatch report.
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It was reported by sales representative after procedure, st modality, a patient - had a reaction post biopsy.Patient complication details: redness and pain to the breast - sent to the er.The customer did not provide the necessary information to determine the severity of harm of the alleged injury.Devicor is reporting on the allegation of injury only.If any new additional relevant information is identified, the injury will be characterized accordingly.This incident has been recorded in complaint #(b)(4).
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