Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Discomfort (2330)
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Event Date 08/20/2018 |
Event Type
Injury
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Manufacturer Narrative
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In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.
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Event Description
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Device 1 of 2.Reference mfr.Report#1627487-2018-08754.It was reported the presented to the emergency room (er) due to discomfort caused by post-operative surgical pain.Reportedly, the patient experienced difficulty swallowing.X-rays were obtained with normal results.Follow-up identified the issue is being treated with medication.
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Event Description
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Device 1 of 2: reference mfr.Report#1627487-2018-08754.
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Event Description
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Device 1 of 2 : reference mfr.Report#1627487-2018-08754.Additional follow-up identified the issue is resolved.
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Search Alerts/Recalls
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