Model Number 102096-67A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Urinary Tract Infection (2120)
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Event Date 05/14/2022 |
Event Type
Injury
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Manufacturer Narrative
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The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
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Event Description
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On (b)(6) 2022, senseonics was made aware of an adverse event that caused the user to be hospitalized.
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Manufacturer Narrative
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This case was created for documentation purpose.User had a urinary tract infection because of which user was hospitalized.This is a non-device related adverse event which does not require any further investigation.User was hospitalized where she was treated for urinary track infection.The user is a subject of post approval study (pas) and the clinic did not provide any details of treatment or resolution.
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Search Alerts/Recalls
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