Model Number 6371 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Erosion (1750)
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Event Date 03/21/2022 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.During processing of this incident, attempts were made to obtain complete event information.Further information was requested but not received.
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Event Description
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It was reported that the patient experienced skin erosion due to the extension.Surgical intervention was undertaken on an unknown date where the extension was explanted and later replaced on (b)(6) 2022.
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Event Description
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Additional information received indicates that surgical intervention was undertaken on (b)(6) 2022, where the extension was explanted and later replaced on (b)(6) 2022.
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Manufacturer Narrative
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Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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Search Alerts/Recalls
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