Reported per clinical trial (b)(4): (b)(6) 2019 - subject patient underwent first time recurrent open midline incisional hernia (6x1 cm) repair procedure during which a bard/davol ventrio hernia patch was implanted.Fascia and full skin closure was achieved with non-bard/davol maxon suture and staples.(b)(6) 2019 - subject patient was diagnosed with an infected wound seroma.(b)(6) 2019 - subject patient was admitted for superficial surgical site infection (ssi).(b)(6) 2019 - subject patient underwent incision and drainage of the wound seroma at the infection site with a liter of saline and betadine.Culture was positive for staphylococcus aureus.The patient was hospitalized until (b)(6) 2019.Per the study clinician, the reported adverse event has been assessed as severe in severity, possibly related to study device and definitely related to the index procedure.The outcome for this ae is reported as resolved.
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As reported, about three weeks post-implant of the bard/davol ventrio mesh, the patient was diagnosed with infected wound seroma and underwent incision & drainage.As reported, the ae is resolved.The clinician has assessed the patient¿s postoperative course as being "possibly" related to the study device and definitely related to the procedure, however, based on the information provided, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification.Seroma formation is a known inherent risk of hernia repair surgery.The adverse reactions section of the instructions-for-use supplied with the device lists seroma as a possible complication.In regards to the infection, the warnings section of the instructions-for-use (ifu) states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." remains implanted.
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