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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E.1:.Phone number: (b)(6).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, right side rupture.Device has been explanted.
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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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Healthcare professional reported right side no complaint against the device.It has been determined that the device associated with this complaint is not pma approved.This record is no longer reportable to the fda and will be un-reported.
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Search Alerts/Recalls
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