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Catalog Number UNK DRAINAGE CATHETER |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Rash (2033); Tachycardia (2095); Wheal(s) (2241); Angioedema (4536)
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Event Date 07/19/2021 |
Event Type
Injury
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Manufacturer Narrative
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As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Device not returned.
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Event Description
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It was reported that post procedure, the patient allegedly experienced rash, low blood pressure/hypotension, hypoxia, tachycardia, angioedema, wheals and erythema.The current status of the patient was unknown.
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Search Alerts/Recalls
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