Based on the information obtained, no conclusion can be made.Postoperative infection is a known inherent risk of surgery.The instructions-for-use (ifu) supplied with the device identifies infection as a possible complication.In regards to infection, the warnings section of the ifu states, "if an infection develops, treat the infection aggressively.An unresolved infection may not have to be removed.An unresolved infection, however, may require removal of the prosthesis." without a lot number, review of the manufacturing records cannot be conducted.Note, the date of event is estimated as (b)(6) 2016 based on the information available.Not returned.
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Per journal article surgical case report 2019 :"mesh removal and reconstruction with posterior components separation technique for delayed mesh infection developed 10 years after abdominal incisional hernia repair: a rare case report": a (b)(6) year-old man, who underwent reconstruction of abdominal incisional hernia by retroperitoneal bard/davol composix mesh application 10 years prior, developed 12 × 6.0 × 2.5 cm subcutaneous abscess followed by (b)(6) related mesh infection.The operation was performed excising the abscess wall (and mesh) without damaging peritoneum, and huge intermuscular defect was successfully reconstructed by posterior components separation technique application.
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