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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 11/09/2023 |
Event Type
malfunction
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Event Description
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The customer has reported that the bulb of the 100% silicone foley catheter deflated after 2-3 weeks of being inserted.
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Manufacturer Narrative
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It was reported by the customer contact that "the bulb of the 100% silicone foley catheter deflated after 2-3 weeks of being inserted".It was reported that due to this, an additional catheter was inserted.No additional information is available.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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