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Model Number DYND11520 |
Device Problem
Burst Container or Vessel (1074)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/19/2023 |
Event Type
malfunction
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Manufacturer Narrative
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According to the customer contact "we have a patient whose catheter balloon deflated/ruptured twice in 2 days.Foley catheter falls out".Due to the reported event the foley catheter was replaced.No additional details were provided.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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Event Description
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Balloon deflated/ruptured requiring replacement.
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Search Alerts/Recalls
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