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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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 a hematoma was observed during the use of the tr band.
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Manufacturer Narrative
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This report is being submitted as follow up no.1 to provide additional information in section b5 and 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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Event Description
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Additional information was received on (b)(6)2019.The account does not believe the device was to blame for the hematoma.
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Search Alerts/Recalls
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