(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.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 an upsylon y-mesh was implanted on (b)(6) 2012.The patient experienced complications.Patient symptoms include: eep (erosion/extrusion/protrusion),back pain, vaginal pain,pelvic pain,groin pain, perineum pain,anal pain,rectal pain,thigh pain,offensive vaginal discharge,difficulties with bowel motions,incontinence not present before implant, recurrent incontinence, damage, and psychiatric injury.
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