Date of event not provided by the complainant.Product common name - anterior pelvic floor graft; product code pag.A review of the device history records indicated the device was manufactured to specifications.Two devices were produced from the lot.A review of the cbi complaint database did not reveal any previously reported complaints involving the reported lot number.The ifu notes that the following complications are possible with the use of surgical graft materials: bleeding, infection, adhesions, sterile effusion, chronic inflammation, allergic reaction, and delayed or failed incorporation of the device.If conditions of infection, inflammation, or allergic reaction cannot be resolved, consider removal of the graft.Based on the information provided by the complainant, details regarding a specific correlation between the surgisis biodesign anterior pelvic floor grafts performance and the alleged injury remain unknown.A root cause of the claim allegations is inconclusive due to the lack of details provided by the complainant.All other matters relating to this litigation are being handled by our attorney.A follow-up mdr will be filed if additional details are obtained.
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The patient was reportedly implanted with a surgisis biodesign anterior pelvic floor graft on (b)(6) 2010, at (b)(6) hospital in (b)(6) , by dr.(b)(6).The patient and her attorney have alleged that as a result of this product being implanted in the patient, the patient has experienced pain, injury, and has undergone medical treatment.
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