The pt was reportedly implanted with a boston scientific obtryx transobturator mid-urethral sling system and a surgisis product on (b)(6) 2011, at (b)(6) medical center in (b)(6), by dr (b)(6).The pt and her attorney have alleged that as a result of these product being implanted in the pt, the pt has experienced pain, injury, and has undergone medical treatment.The following info was not provided by the complainant: specific info of the alleged injury; specific info regarding whether intervention was performed; specific info regarding why intervention was performed or what type / to what extent intervention was performed; specific correlation between device performance and alleged injury; current pt status.
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As requested by the fda, we have made note of the product code.Conclusions code: root cause inconclusive due to lack of details provided by the complainant.Investigation-eval: investigation into this claim has 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 surgisis product's performance and the alleged injury remain unk.A root cause of the claim allegations 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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