Catalog Number 68-420 |
Device Problems
Break (1069); Fluid/Blood Leak (1250)
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Patient Problem
Failure of Implant (1924)
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Event Date 04/20/2023 |
Event Type
Injury
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Manufacturer Narrative
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A review of the device history record has been completed.No deviations or non-conformances noted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: deflation.
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Event Description
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Healthcare professional reported a right side deflation.The device remains implanted.
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Event Description
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Device has been explanted and replaced.
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Manufacturer Narrative
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Device evaluation: based on the device analysis grid, the assessments of the complaint are: deflation: valve leak and or damage: delamination observed assessed as adhesive failure.Additional observations: creases were observed.Wear abrasion observed.White particles observed inner on the device.No further actions are required as no manufacturing issues are observed.
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Event Description
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Healthcare professional later reported "hole in valve".
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Search Alerts/Recalls
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