Patient identifier: (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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It was reported to boston scientific corporation that a upsylon y-mesh implant and a obtryx implant were implanted into the patient on (b)(6) 2011.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: pelvic pain; perin pain; off vag dis; diff bowel.Surgical interventions: on (b)(6) 2021 the patient underwent further surgery regarding the obtryx implant under general anesthesia for the following purpose: cystoscopy with retrograde pyelogram to try and find out why i was getting recurrent uti s and blood in the urine and infections.Nonsurgical treatments: on (b)(6) 2017 the patient commenced pain medication: paracetamol for the treatment of: pain.Treatment duration: continual.On (b)(6) 2017 the patient commenced other medication (please specify): ural for the treatment of: relieve pain.Treatment duration: when episodes of cystitis occurs.On (b)(6) 2011 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: strengthen pelvic area.Treatment duration: on and off.The patient was treated with topical treatment (including oestrogen cream): canesten for the treatment of: clear infection.Treatment duration: on and off.On (b)(6) 2017 the patient commenced pain medication: nurofen for the treatment of: pain and throbbing.Treatment duration: continual.
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