A batch review of the finished good lot and components confirmed there were no quality issues noted throughout the incoming inspection, manufacturing, sterilization, in-process, or final inspection process.To date samples or photos have not been returned for review and/or analysis.Without receiving details of the procedure, placement of the device, culture results and patient health history, a definitive root cause for the reported event of infection cannot be confirmed with certainty adverse effects associated with the use of this device may include, wound dehiscence, failure to provide adequate wound support in closure of the site where expansion, stretching or distension occur, failure to provide adequate wound support in elderly, malnourished or debilitated patients or in patients suffering from condition which may delay wound healing, infection, minimal acute inflammatory tissue reaction, localized irritation which skin sutures are left in place for greater than 7 days, suture extrusion and delayed absorption in tissue with poor blood supply, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs and transitory local infection at the wound site.Infections, erythema, foreign body reactions, transient inflammatory reactions and in rare instances dehiscence are typical or foreseeable risks associated with any suture and hence are also potential complications associated with the barbed suture device.Pdo (polidioxanone) material is essentially absorbed between 182 and 238 days post implantation.However, this specific material has in vivo strength retention for up to six (6) weeks.All sutures are technically ¿foreign substances¿ that the human body has a tendency to reject.Ideally this means the body breaks them down and dissolves them over a period of 3 or 4 months.
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Post-op infection.This case is from health authority.It was reported that the patient was treated with a johnson & johnson surgical knot- free suture for the caesarean section incision suture.Three months plus later, it was found that the wound sewed had been infected.The thread tip of the suture had been extruded out of the abdominal incision, where also had an ulcer.The incision was currently healed after cutting off the extruded thread tip.No additional information could be provided.
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