Model Number 1192 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Fluid Discharge (2686)
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Event Date 04/12/2019 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided on the final report.Further information was requested but not received.
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Event Description
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Manufacturer report number 1627487-2019-05058.Manufacturer report number 1627487-2019-05059.Manufacturer report number 1627487-2019-05060.It was reported that a small amount of drainage issue was observed at the anchor sites.Cultures were taken however results were not provided.No infection was confirmed.An incision drainage procedure was completed on (b)(6) 2019 and the device system remains implanted.Patient was stable.
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Event Description
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Manufacturer report number 1627487-2019-05058.Manufacturer report number 1627487-2019-05059.Manufacturer report number 1627487-2019-05060.
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Search Alerts/Recalls
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