ALLERGAN (COSTA RICA) UNK MAMMARY IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
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Catalog Number UNK MAMMARY IMPLANT |
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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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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Event Description
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Healthcare professional reported "rupture diagnosed with instrumental test".This relates to the right side.Device remains implanted.
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Manufacturer Narrative
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Additional, changed, and/or corrected data: a2, b2, b5, d3, d6b, g1, h6.
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Event Description
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Healthcare professional later reported no complaint against the right side device.Device has been explanted and replaced with non allergan device.
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Search Alerts/Recalls
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