The patient was reportedly implanted with a biodesign or surgisis urethral sling on (b)(6) 2013, at (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.The following information was not provided by the complainant: specific information of the alleged injury; specific information regarding whether intervention was performed; specific information regarding why intervention was performed or what type / to what extent intervention was performed; specific correlation between device performance and alleged injury; current patient status.
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Conclusions: root cause inconclusive due to lack of details provided by the complainant.Investigation eval: investigation into this claim included a review of the claim allegations and all other communication and investigation into this report/claim is being handled by our attorney.Summary of investigation findings: based on the info provided by the complainant, details regarding a specific correlation between the biodesign or surgisis urethral sling's performance and the alleged injury remain unk.A root cause of the claim allegation is inconclusive due to lack of details provided by the complainant.All other matters relating to this litigation are being handled by our attorney.If/when additional info is obtained, a follow-up mdr will be filed.
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