Phone number: (b)(4).Facility address: (b)(6).The device was not returned and the lot number of the device was unknown; therefore, a sample analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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It was reported that within an hour into treatment with one unit of revaclear 400, a patient experienced allergic symptoms manifested by dyspnea and abdominal pain.The patient was treated with intravenous dexamethasone 10 mg, intramuscular injection of anisodamine (10mg) and tramadol hydrochloride (100mg).The patient was reported to be stable.No additional information is available.
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