Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Fever (1858)
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Event Date 08/10/2017 |
Event Type
Injury
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Manufacturer Narrative
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In the event the devices are returned to the manufacturer, no analysis will be performed as 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: 1627487-2017-05243.It was reported the patient had her scs system removed due to infection.Reportedly, the patient experienced a fever and was evaluated in the emergency room (er).Cultures taken were positive for (b)(6) infection.The patient was treated with iv antibiotics and was to continue on the antibiotics for six weeks.
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Event Description
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Reference mfr report: 1627487-2017-05243.
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Search Alerts/Recalls
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