This legal event is being reported as serious injury due to the reported recurrence with surgical intervention.
The lot associated with this event was not reported and remains unknown; therefore a review of the device history records could not be performed.
No strattice devices were returned for evaluation.
Based on the limited information reported, a relationship between the event and strattice cannot be confirmed.
Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.
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It was reported through a legal event that a (b)(6) year old female patient had hernia repair surgery on or about (b)(6) 2013.
During the hernia repair surgery, the surgeon implanted a strattice firm mesh.
The patient had revision surgery on (b)(6)2016, during which mesh was removed and additional strattice mesh was implanted.
The patient returned to the hospital for additional revision surgeries on (b)(6)2016, and (b)(6) 2016.
This record is associated with the second device implanted on (b)(6) 2016.
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