Model Number 3086 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Headache (1880); Vomiting (2144)
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Event Date 07/06/2015 |
Event Type
Injury
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Event Description
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It was reported the patient underwent a trial procedure on (b)(6) 2015.During the procedure, it was noted there was saline water bubbling back out of the epidural needle when the stylet was removed.The patient experienced severe headache and vomited after the surgery.A cerebrospinal fluid leak was not confirmed, however, a blood patch was applied.Follow-up revealed the issue had resolved over time.
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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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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 #: 1627487-2015-07478.Further device information has been included.Therefore, an additional report was included pertaining to the event.
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Search Alerts/Recalls
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