ALLERGAN (COSTA RICA) STYLE 68 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
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Catalog Number 68-390 |
Device Problems
Fluid/Blood Leak (1250); 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 Date 08/29/2023 |
Event Type
Injury
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Event Description
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Healthcare professional reported right side deflation.Device has been explanted and replaced.
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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: deflation.
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Event Description
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Previous medwatch submission noted deflation.Upon further information, allergan has determined that the event of deflation did not occur.
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Event Description
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Healthcare professional reported right side deflation.Device has been explanted and replaced.
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Search Alerts/Recalls
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