Model Number IPN039839 |
Device Problem
Structural Problem (2506)
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Patient Problem
Ecchymosis (1818)
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Event Date 05/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Qn# (b)(4).
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Event Description
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It was reported "the chief of anesthesia informed me that two ent doctors said that the tip of the cuff was causing trauma/bruising to the patient's epiglottis".No patient desaturation reported.No medical intervention required.Patient condition reported as "fine".
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Event Description
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It was reported "the chief of anesthesia informed me that two ent doctors said that the tip of the cuff was causing trauma/bruising to the patient's epiglottis".No patient desaturaton reported.No medical intervention required.Patient condition reported as "fine".
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Manufacturer Narrative
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Qn#(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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