Catalog Number UNK_SPE |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Abdominal Pain (1685); Dysphagia/ Odynophagia (1815); Pain (1994); Swelling/ Edema (4577)
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Event Date 04/26/2021 |
Event Type
Injury
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Manufacturer Narrative
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Status and location of the device is unknown.
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Event Description
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This event captures a review of a (b)(6) clinical study.No further device information is available.Patient twenty-nine experienced a prolonged hospital visit due to acute respiratory distress and aspiration pneumonia; problems swallowing, worsening cough and dysphagia post-operatively.These issues resolved following surgical intervention.
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Manufacturer Narrative
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Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records could not be reviewed as a valid lot number was not provided and could not be obtained.No device information nor additional information about the procedure was provided.There is no stryker device failure reported via this complaint therefore no investigation can be performed.If additional information is received, this investigation will be reopened and updated.
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Event Description
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This event captures a review of a capri clinical study.No further device information is available.Patient twenty-nine experienced a prolonged hospital visit due to acute respiratory distress and aspiration pneumonia; problems swallowing, worsening cough and dysphagia post-operatively.These issues resolved following surgical intervention.
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Search Alerts/Recalls
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