Patient was admitted to the hospital for assessment.After several days of testing and observation, the treating physician reported that the patient has a fungal infection which is presenting symptoms similar to a hypersensitivity reaction.The patient is undergoing treatment for the fungal infection.Treating physician has ruled out the device as contributing to the reported event.No additional information about the patient is known at this time.No testing on the specific device has been conducted.The marker remains in the patient and the applicator portion was disposed of at the conclusion of the biopsy procedure per internal medical facility procedures.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.Due to the medical intervention and extended hospitalization, although not directly related to use of our device, pursuant to 21 cfr 803, we are submitting this medwatch report.Device not returned to mfr.
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