ALLERGAN (COSTA RICA) INSPIRA SMOOTH COHESIVE SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
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Catalog Number SCF-520 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Foreign Body Reaction (1868)
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Event Date 02/02/2024 |
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: "bulging" and "rejection".
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Event Description
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Healthcare professional reported, "bulging" and "rejection".And "patient's body rejecting implants, bulging under skin".This record is for the right side.Device remains implanted.
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Event Description
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Healthcare professional reported right side "bulging" and "rejection" and "patient's body rejecting implants, bulging under skin".The device has been explanted.
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Manufacturer Narrative
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Device evaluation: a review of the device noted deformation was observed.
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Search Alerts/Recalls
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