The mammomark 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 by x-ray and mri.The device has not been returned for evaluation, which prevents a full investigation and analysis of the root cause at this time.However, this failure has been identified in the risk management file for the effects of potential hypersensitivity with a potential for injury to the patient and/or user.Follow up medical intervention may be necessary.Although it could not be concluded that our device caused or contributed to this event, through evaluation by our medical advisor on similar events, 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 the doctor, post procedure, customer works with eviva system.Allergic reaction suspected to the insertion and the material of a marker after vab.The patient has a problem, that the doctor mad a recommendation to remove the clip by surgery or vacuum biopsy.
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