Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Cellulitis (1768)
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Event Date 08/26/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Manufacturer¿s evaluation: the complaint of infection cannot be confirmed 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.(b)(4).
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Event Description
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Device 1 of 3: reference mfr.Report: 3006705815-2016-00418; reference mfr.Report: 1627487-2016-04808.It was reported the patient had an 'indentation' at the lead incision site which was diagnosed as cellulitis.The patient was given intra-venous and oral antibiotics.As of (b)(6) 2016, the patient's cellulitis was reportedly improving.The patient has two anchors with the same lot number.
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Manufacturer Narrative
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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 1 of 3.Reference mfr.Report: 3006705815-2016-00418.Reference mfr.Report: 1627487-2016-04808.Follow-up identified the patient is no longer being treated with antibiotics.The patient was advised to monitor the incision site closely as it continues to heal.
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Search Alerts/Recalls
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