Model Number N/A |
Device Problem
Leak/Splash (1354)
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Patient Problem
Blood Loss (2597)
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Event Type
malfunction
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Manufacturer Narrative
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Expiration date - unknown due to lot number being unknown.Udi - unknown due to lot number being unknown.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date - unknown due to lot number being unknown.The actual device was not returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record and complaint files.
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Event Description
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The user facility reported that the involved tr band deflated.The tr band was placed, and the patient was transferred to a stretcher for transport to recovery when bleeding was noticed.Hemostasis was achieved manually, followed by new tr band, which was applied successfully.The blood loss was less than 250cc.The patient was in stable condition.The procedure outcome was successful with a second tr band.
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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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