Catalog Number 192050 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Numbness (2415)
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Event Date 10/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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Customer reports patients experiencing tongue numbness for a period of days or several weeks following anesthesia using the lma protector.The cases are performed with the patient in a supine position with their head and neck in neutral and the cuff pressure is measured using a manometer and the pressure maintained between 40-60 cm of water.No report of a required intervention.Tongue numbness resolved.The patient's condition is reported as fine.
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Event Description
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Customer reports patients experiencing tongue numbness for a period of days or several weeks following anesthesia using the lma protector.The cases are performed with the patient in a supine position with their head and neck in neutral and the cuff pressure is measured using a manometer and the pressure maintained between 40-60 cm of water.No report of a required intervention.Tongue numbness resolved.The patient's condition is reported as fine.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Search Alerts/Recalls
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