Catalog Number 133MV-13 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Capsular Contracture (1761)
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Event Date 07/25/2019 |
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.The event of capsular contracture is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Reason for reoperation due to capsular contracture, baker grade unknown.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.
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Event Description
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Healthcare professional reported right side capsular contracture, baker grade unknown and the device being implanted for more than 6 months.Device has been explanted.
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Event Description
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Healthcare professional reported right side capsular contracture, baker grade unknown and the device being implanted for more than 6 months.Device has been explanted.
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Manufacturer Narrative
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Device evaluation: analysis of the returned device identified yellow biological tissue.Leak test and microscopic analysis was performed which identified: no leakage and crease flat.Based on the device analysis the final assessment is: no issues found related with the manufacturing process.
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Search Alerts/Recalls
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