Model Number N/A |
Device Problem
Inflation Problem (1310)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Date of event - (b)(6) 2020.Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record of the product code/lot# combination was conducted with no findings.[uf medwatch (b)(4).Pdf].
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Event Description
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Terumo medical received a user facility medwatch report # (b)(4).The event description states: bladder malfunctioned.The one-way valve did not hold the air in the bladder.When the inflator was removed the air escaped.Another device was used to obtain hemostasis.
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Manufacturer Narrative
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This report is being submitted as follow up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.
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Search Alerts/Recalls
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