Model Number 3186 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Date 12/08/2014 |
Event Type
Injury
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Event Description
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Device 2 of 2 reference mfr.Report: 1627487-2014-03794.
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Event Description
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Device 2 of 2.Reference mfr.Report: 1627487-2014-03794.
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Event Description
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Device 2 of 2.Reference mfr.Report: 1627487-2014-03794.
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Manufacturer Narrative
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(b)(4).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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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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Manufacturer Narrative
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The explant and replacement(different model)/explant date was inadvertently omitted from the initial report.The explant date has been added.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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Search Alerts/Recalls
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