Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Discharge (2225)
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Event Date 03/28/2018 |
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 2 of 2.Reference mfr.Report: 1627487-2018-03832.It was reported (b)(6) the patient experienced drainage in the incision site which would occur occasionally.Upon inspection, the wound site was open.The wound site showed signs of improvement when assessed at a follow-up visit.The patient was prescribed antibiotics.
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Event Description
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Device 2 of 2.Reference mfr.Report: 1627487-2018-03832.Follow-up identified the patient completed the antibiotics course.There have been no further complaints from the patient with respect to the scs system.
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Event Description
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Device 2 of 2.Reference mfr.Report: 1627487-2018-03832.Follow-up indicated the patient's infection has resolved following the completion of the antibiotics course.
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Search Alerts/Recalls
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