Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cerebrospinal Fluid Leakage (1772); Headache, Lumbar Puncture (2186)
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Event Date 09/28/2016 |
Event Type
Injury
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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.(b)(4).
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Event Description
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Device 1 of 2.Reference mfr report: 3006705815 -2016-00522.It was reported that a wet tap was observed during an implant surgery on (b)(6) 2016 (reference mfr report: 3006705815-2016-00514 and 3006705815-2016-00515).In addition, the physician performed a blood patch.Post-op, the patient experienced a headache.Current patient condition is unknown at this time.
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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 2.Reference mfr report: 3006705815-2016-00522.The issue is resolved.
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Search Alerts/Recalls
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