Catalog Number UNKNOWN |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problems
Pain (1994); Injury (2348)
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Event Type
Injury
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Event Description
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The patient was reportedly implanted with a stratasis urethral sling on (b)(6) 2007, at (b)(6) hospital in (b)(6), by dr.(b)(6).The patient and her attorney have alleged that as a result of these products 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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Manufacturer Narrative
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Date of event not provided by the complainant.Lot number not provided by the complainant; product expire date unknown; lot number not provided; product catalog number unknown, product unspecified.Conclusion - root cause inconclusive due to lack of details provided by the complainant.Investigation into this claim included a review of the claim allegation and all other communication and investigation into this report/claim is being handled by our attorney.Based on the information provided by the complainant, details regarding a specific correlation between the stratasis urethral sling's performance and the alleged injury remain unknown.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 information is obtained a follow-up mdr will be filed.
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Manufacturer Narrative
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Update: the root cause of the patient¿s current complaints is inconclusive.However, the patient appears to have had the same complaints prior to the implantation of the surgisis graft.
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Event Description
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The patient was reportedly implanted with a stratasis urethral sling on (b)(6) 2007, 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.Update: in (b)(6) 2007, dr.(b)(6) performed a vaginal reconstruction and creation of a neovagina with use of a surgisis graft, for treatment of dyspareunia and pelvic pain.The patient reported experiencing vaginal spasms, which began sometime after this surgery.In (b)(6) 2011, dr.(b)(6) at (b)(6), performed surgery on the patient for removal of a fibroepithelial polyp.
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Search Alerts/Recalls
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