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 week, and be permanently visible by x-ray and mri.The device has not been returned for evaluation, which prevents a full investigation and analysis of a root cause at this time.However, this failure mode has been identified in the risk management file for the effects of potential foreign body reaction 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.
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Devicor medical products, inc.Received a report from the user facility stating, a butterfly shaped titanium hydromark marker was placed in (b)(6) 2018.The patient complained of pain since that time and requested removal of the marker.The clip was removed (b)(6) 2019.This has been documented in our system as record # (b)(4).
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