Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hematoma (1884)
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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.Pma/510(k) - unknown due to lot number being unknown.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 an issue with the involved tr band.Additional information was received on july 15, 2019.The patient had a small hematoma developing; and they placed another tr band over top of the first band while it was still on the patient.The patient was reported to be in stable condition.
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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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