The patient reported infection, pain, tenderness and wound not healing.Antibiotics were prescribed.Attempts to contact the patient for additional information were made.However, attempts were unsuccessful and no additional information was provided.
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The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device after the expiration date, not preparing the skin with an antiseptic solution, the patient not attending the post-op visit, using incorrect tools, and multiple tunneling attempts have been ruled out as potential causes.Other potential causes of the reported issue are patient non-compliance (touching/picking at the wound), implanting a non-sterile device, not using antibiotics preoperatively, not irrigating the site with antibiotic solution before closure, not implanting in the sterile field, and patient contraindicating conditions.A curonix representative conducted a review of sterilization and packaging records for the respective product lot; curonix has confirmed that the product was delivered sterile, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging. the stimulator is used to treat pain.The investigation findings do not lead to a clear conclusion about the cause of the reported issue.Therefore, conclusion has been selected as unable to determine root cause.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in surgical issues.Surgical issue rates remain acceptably low; thus, capa is not required. surgical issue rates will continue to be tracked and trended.
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