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 Date 01/17/2024 |
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/will be requested.No additional information is available at this time.Reason for reoperation: rupture.
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Event Description
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Patient reported left side rupture.The 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 completed.No deviations or non-conformances noted.
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Event Description
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Patient reported left side rupture.The device has been explanted and replaced.
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Event Description
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Previous medwatch submission noted rupture.Upon further information, abbvie has determined that this record is a duplicate record.Please see mdr 9617229-2024-02403 as the operating record related to this complaint.
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Search Alerts/Recalls
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