(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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Note: two boston scientific mesh devices were implanted into the same patient.This report pertains to the upsylon y-mesh.It was reported to boston scientific corporation that an uphold implant and an upsylon y-mesh implant were implanted into the patient on an unspecified date.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; groin pain; rectal pain; thigh pain; inability to have intercourse; offensive vaginal discharge; difficulties with bowel motions; incontinence not present before implant; recurrent incontinence; aggravated incontinence; other pain: urinary tract infections surgical interventions: on an unspecified date the patient underwent further surgery regarding the upsylon y-mesh implant for the following purpose: to have the mesh removed as it impacted the bladder and caused erosion and pain, which is why patient had to have it removed; she suffered lots of pain and bleeding.Nonsurgical treatments: on (b)(6) '2021 the patient commenced pain medication: cefalexin sandoz 500mg for the treatment of urinary tract infection.Treatment duration: 5 days.On (b)(6) 2021 the patient commenced incontinence medication: curam duo amoxicillin tri hydrate 500mg clavulanic 125 mg as the other medication was not the right medication to treat the infection.Treatment duration: 5 days.
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