It was reported to boston scientific corporation that a upsylon y-mesh was implanted into the patient on (b)(6) 2015.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; thigh pain; offensive vaginal discharge; incontinence not present before implant; damage nonsurgical treatments: the patient was treated with physiotherapy treatment for purpose: trying to strengthen walls and incontinence.The patient was treated with other: incontinence liners for the treatment of: incontinence - changing 4-5 times a day.On (b)(6) 2019 the patient commenced physiotherapy treatment: neotonus pelvic floor exercise chair to further improve pelvic floor muscles.Treatment duration: 5-6 sessions.
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(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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