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Catalog Number DYND11502 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
Insufficient Information (4580)
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Event Date 08/03/2023 |
Event Type
malfunction
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Event Description
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Foley catheter balloon burst and catheter replaced.
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Manufacturer Narrative
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A healthcanada report was received that indicated the balloon ruptured and the foley cathether had to be replaced.No additional information was provided related to the reported incident.A sample was requested to be returned for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
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Search Alerts/Recalls
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