(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 upsylon y-mesh and an obtryx sling were implanted into the patient on (b)(6) 2012.The patient subsequently experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: back pain; vaginal pain; pelvic pain; groin pain; thigh pain; painful intercourse; offensive vaginal discharge; difficulties with bowel motions; incontinence not present before implant; recurrent incontinence; aggravated incontinence; damage; psychiatric injury.Surgical interventions: on (b)(6) 2021 the patient underwent further surgery regarding the obtryx implant under local anesthesia for the following purpose: dilate a stenosed urethra.
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