Model Number 3086 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Muscle Spasm(s) (1966)
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Event Date 01/30/2015 |
Event Type
Injury
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Event Description
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The patient's date of birth is unknown.On (b)(6) 2015, the patient underwent a trial procedure.During the procedure, the patient began to experience back spasms after the needle was placed in her skin.The doctor decided to abandon the procedure due to the patient being unable to remain still.
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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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The returned product was not analyzed as the complaint of "abandoned procedure' could not 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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Search Alerts/Recalls
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