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Model Number URO170716 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/11/2023 |
Event Type
Injury
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Manufacturer Narrative
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According to the customer, the patient had a foley inserted on (b)(6) 2023 and there was "balloon disruption" causing the foley to come out "hours after" leaving the urologist.The customer reported an additional catheter was placed in the "ed" and the balloon was found with a "longitudinal split".According to the customer the patient denies any "pulling/trauma".No additional information is available at this time.The sample was requested for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.
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Event Description
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According to the customer, the patient had a foley inserted on (b)(6) 2023 and there was "balloon disruption" causing the foley to come out "hours after" leaving the urologist.
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Search Alerts/Recalls
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