Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Respiratory Distress (2045)
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Event Date 01/08/2015 |
Event Type
Injury
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Event Description
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On (b)(6) 2015, the patient underwent a permanent implant procedure.The patient experienced respiratory/pulmonary distress near the end of the procedure, but eventually was stable.In turn, the procedure was extended by an hour.It was also reported the patient experienced wheezing the following day.Further patient and device information are unknown.
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Event Description
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Device 1 of 2.Reference mfr.Report#: 1627487-2015-05105.Further patient and device information was gathered.In turn, an additional report is being added.
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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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Udi (di): (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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Search Alerts/Recalls
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