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Model Number DYND11502 |
Device Problems
Material Rupture (1546); Device Fell (4014)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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It was reported that the customer is a home health patient who uses foley catheters for chronic medical use.The facility director reported that the balloon of the catheter became fully deflated and the catheter fell out of the patient shortly after being secured, requiring a new catheter to be placed.The nurse reported that the catheter was placed on (b)(6) 2021 and the issue was noticed on (b)(6) 2021 at which time a new catheter was inserted.The actual sample was disposed of and is not available to be returned for evaluation.There is no additional information available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
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Event Description
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It was reported that the balloon of the catheter became fully deflated and the catheter fell out of the patient shortly after being secured requiring a new catheter to be placed.
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Search Alerts/Recalls
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