ALLERGAN (COSTA RICA) INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
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Catalog Number SRF-450 |
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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Manufacturer Narrative
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A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.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: "ruptured, punctured¿.
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Event Description
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Healthcare professional reported, "rupture, punctured".This record is for the right side.Device was explanted.
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Event Description
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Healthcare professional reported "rupture, punctured" which is not device related.
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Manufacturer Narrative
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Clarification to h1- "rupture, punctured" is not device related.
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Search Alerts/Recalls
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