Model Number 102 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Dysphagia/ Odynophagia (1815); No Information (3190)
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Event Date 08/28/2020 |
Event Type
Injury
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Event Description
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It was reported that a patient had a "laryngeal side effect." this side effect resulted in disablement of the device.The patient was then referred for explant.It was reported that this explant was due to the device bothering the patient when active.No surgical intervention has occurred to date.No additional relevant information has been received to date.
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Manufacturer Narrative
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F10: patient event code: corrected data - dysphagia was added as the event term due to the side effect's description as laryngeal.
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Event Description
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It was reported that the patient's device was explanted.The suspect product has not been received to date.No additional information has been received to date.
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Search Alerts/Recalls
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