ALLERGAN (COSTA RICA) STYLE 68 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
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Catalog Number 68HP-750 |
Device Problem
Break (1069)
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Patient Problem
Failure of Implant (1924)
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Event Date 02/16/2024 |
Event Type
Injury
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Event Description
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Sales representative reported "hole in the implant".This record is for the unknown side.Device was not implanted.
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Manufacturer Narrative
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Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.A review of the device history record has been completed.No deviations or non-conformances noted.Reason for reoperation: break.
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Manufacturer Narrative
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Additional, changed, and/or corrected data.Photo analysis: it is not possible to determine the lot number or catalog through the photos provided.Visual analysis of the photographs identified: broken device: observed, opening on the device but cannot perform an assessment of the opening as no microscopic analysis can be performed.
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Event Description
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Healthcare professional reported "hole in the implant".
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Search Alerts/Recalls
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