ALLERGAN (COSTA RICA) INSPIRA SMOOTH COHESIVE SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
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Catalog Number SCX-700 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Wound Dehiscence (1154); Foreign Body Reaction (1868)
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Event Date 02/19/2024 |
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.The events of exposure and wound dehiscence are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Further information from the reporter regarding event, product, or patient details has been/will be requested.No additional information is available at this time.Reason for reoperation: "implant exposed from wound dehiscence.".
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Event Description
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Healthcare professional reported right side "implant exposed from wound dehiscence".The device has been explanted and replaced.
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Search Alerts/Recalls
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