Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Purulent Discharge (1812)
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Event Date 07/30/2015 |
Event Type
Injury
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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.(b)(4).
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Event Description
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Device 3 of 3.Reference mfr.Report#: 1627487-2015-05409.Reference mfr.Report#: 1627487-2015-05410.
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Manufacturer Narrative
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(conclusion code) (after further review, the codes that were initially reported were incorrect.) the complaint of pus at the lead site 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.
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Event Description
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Device 3 of 3.Reference mfr.Report#: 1627487-2015-05409, reference mfr.Report#: 1627487-2015-05410.
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Search Alerts/Recalls
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