Based on the information provided, no conclusion can be made.As alleged, the patient experienced post-implant adverse outcomes including infection and, gangrene with subsequent mesh removal.Review of the manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in january, 2019.Infection is a known inherent risk of surgery.Regarding infection the instructions-for-use, supplied with the device, 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." this mdr represents the bard/davol perfix plug (device #1).An additional mdr was submitted to represent the bard/davol perfix plug (device #2).
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The following was reported via maude event report (mw5105877): "caller stated that he was implanted with a mesh (b)(6) 2019.One on the right side of the groin and another on the left side.Pt stated after implantation he started to experience pain in the groin area.Pt met with his doctor to discuss his symptoms, while he was at the doctor's office he fainted, he was later revived.Patient stated when he got home after meeting with his doctor he noticed that his body is inflamed and red.His son took him to the emergency room where he was admitted to the hospital.He was in the hospital for two weeks because he develop gangrene and his wound was infected.He was placed on antibiotics, he continued to received treatment until his wound is cleared from infection and healed.On (b)(6) 2021 the mesh was explanted." addendum per additional information: as reported, the patient was implanted with two perfix plugs, underwent explant of both meshes and the patient continues to seek treatment.
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