It was reported to boston scientific corporation that an upsylon y-mesh was implanted 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; thigh pain; inability to have intercourse; offensive vaginal discharge; difficulties with bowel motions; incontinence not present before implant; recurrent incontinence; aggravated incontinence; damage; psychiatric injury.Surgical interventions: on an unspecified date the patient underwent further surgery regarding the upsylon y-mesh implant under general anesthesia for the following purpose: cystoscopy.On an unspecified date the patient underwent further surgery regarding the upsylon y-mesh implant under general anesthesia for the following purpose: cystoscopy.On an unspecified date the patient underwent further surgery regarding the upsylon y-mesh implant under general anesthesia for the following purpose: cystoscopy.On an unspecified date the patient underwent further surgery regarding the upsylon y-mesh implant under general anesthesia for the following purpose: cystoscopy.On an unspecified date the patient underwent further surgery regarding the upsylon y-mesh implant under general anesthesia for the following purpose: cystoscopy.On an unspecified date the patient underwent further surgery regarding the upsylon y-mesh implant under general anesthesia for the following purpose: cystoscopy.Nonsurgical treatments: the patient was treated with pain medication.The patient was treated with incontinence medication.The patient was treated with topical treatment (including oestrogen cream).
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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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