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
Injury
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Manufacturer Narrative
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Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date - unknown due to unknown product code/lot number.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.
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Event Description
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The user facility reported a possible hematoma that was associated with a tr band.They indicated that one variable with the case was the reintroduction of heparin, 1-hour post band removal.
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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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