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Catalog Number DYND11533 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/11/2024 |
Event Type
malfunction
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Event Description
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"the balloon popped while in the patient".
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Manufacturer Narrative
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It was reported by the customer contact that a foley catheter was in place for cervical dilation.It was reported that after several hours in place, "the balloon popped while in the patient".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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