ALLERGAN (COSTA RICA) INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
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Catalog Number SSLP-235 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Foreign Body Reaction (1868)
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Event Type
Injury
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Event Description
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Healthcare professional reported, left side "exposed".Device has been explanted and replaced.
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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 "exposure" is a physiological complication.And analysis of the device generally does not assist allergan in determining a probable cause for this event.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: "exposed".
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Search Alerts/Recalls
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