(b)(6).The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.The complainant indicated that the device is not available for return; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation that a upsylon y-mesh was implanted into the patient on (b)(6) 2014.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: back pain; pelvic pain; rectal pain; difficulties with bowel motions surgical interventions: on (b)(6) 2016 the patient underwent further surgery regarding the upsylon y-mesh implant under general anesthesia for the following purpose: removal of suture broken through the skin of the vaginal wall.Nonsurgical treatments: on (b)(6) 2014 the patient commenced pain medication: anti inflammatory which caused a severe stomach ulcer - now on pariet 20mg daily ongoing for ulcer.Tramadol now palexia for purpose: anti inflammatory for lower back pain - then pain relief.Treatment duration: ongoing.
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