Based on the information provided, no conclusion can be made.Postoperative complications of hernia recurrence and infection are known inherent risks of surgery/use of the device.The warning section of the instructions-for-use, supplied with the device states, ¿to prevent recurrences when repairing hernias, the prosthesis should be large enough to extend beyond the margins of the defect.¿ and ¿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." review of manufacturing records confirms product was manufactured to specification.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in september 2021.The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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As per (b)(6) (china fda): as reported, during an laparoscopic bilateral indirect inguinal hernia repair procedure on (b)(6) 2022 under general anesthesia, the urologist implanted a hernia repair patch (bard/davol 3dmax light mesh) into the patient.The operation went well and the patient was discharged on (b)(6) 2022.It was reported that on (b)(6) 2022, the patient complained of skin swelling, pain and discomfort at the incision for a week, and was hospitalized again.The urologist performed abdominal wall debridement and drainage on the patient, and the operation went well.After symptomatic drainage and anti-inflammatory treatment, the patient improved and was discharged on (b)(6) 2022.As reported, on (b)(6) 2022, the patient was found to have a reducible mass in the right groin area one month ago, which gradually increased, and was further treated and hospitalized again.The doctor performed a tension-free repair of the right indirect inguinal hernia on (b)(6) 2022.During the operation, the bard/davol 3dmax light mesh was sutured and fixed to the pubic tubercle, lacuna ligament, syndesmotic tendon and inguinal ligament, and the operation went smoothly.After symptomatic treatment, the patient's condition improved and he was discharged on (b)(6) 2022.The doctor suspected that the hernia repair patch had infection and rejection after laparoscopic bilateral indirect inguinal hernia repair, or that the patch had no self-adhesive effect and was easily displaced after surgery.In addition, there are factors such as low self-immunity in patients.
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