Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cellulitis (1768); Post Operative Wound Infection (2446)
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Event Date 03/07/2017 |
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.Sjm 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.Sjm defers to the patient's physician regarding medical history.
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Event Description
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Device 3 of 3.Reference mfr report: 1627487-2017-01667.Reference mfr report: 3006705815-2017-00322.It was reported the patient¿s entire scs system was removed due to a cellulitis infection (unknown location).The patient is being treated with antibiotics.
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Event Description
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Device 3 of 3: reference mfr report: 1627487-2017-01667, reference mfr report: 3006705815-2017-00322.Follow up information identified the infection has resolved.
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Search Alerts/Recalls
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