Device is a combination product.Device evaluated by mfr: the device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).
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Same case as mdr id # 2134265-2018-01738, 2134265-2018-01739, 2134265-2018-01740, 2134265-2018-01742 it was reported that an allergic reaction occurred.In (b)(6) 2018, five synergy ii stents were implanted in a patient (4.0x16, 3.0x24, 2.25x16, 3.5x24, 3.0x24).The next morning, the patient's throat was swollen and within another 12 hours, the patient's throat and mouth were full of ulcers/sores.One week later, the patient's condition has not improved.The ear nose throat doctor has prescribed treatment of a topical lidocaine.The patient is not getting any better and is only able to drink things but can't eat because of the open sores.
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