Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/04/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Expiration date - unknown due to unknown lot number.Udi - unknown due to unknown lot number.Implant date (2021 reports): implanted date: device was not implanted.Explant date (2021 reports): explanted date: device was not explanted.Device manufacturer date - unknown due to unknown 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 that they had bleeding complications with a tr band device in the catheterization lab.
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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.Since the sample was not available for evaluation, the complaint could not be confirmed.The exact root cause cannot be determined.The dhr could not be reviewed since no lot number was available.Currently no action is recommended since this risk evaluation is within the predetermined limits in the fmea.
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Search Alerts/Recalls
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