SANTA BARBARA STYLE 410 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
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Catalog Number N-ST-MM130-360 |
Device Problems
Material Rupture (1546); No Apparent Adverse Event (3189)
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Patient Problems
Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Event Description
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Healthcare professional, left side rupture.Device has been explanted.
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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.Reason for reoperation: rupture.
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Manufacturer Narrative
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Additional, changed, and/or corrected data.
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Event Description
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It has been determined that the device associated with this complaint is not pma approved.This record is no longer reportable to fda and will be un-reported.
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Search Alerts/Recalls
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