(b)(4).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 an unspecified prolapse implant (pinnacle/ pinnacle lite/ uphold/ uphold lite/ upsylon y-mesh) was implanted on an unspecified date.The patient experienced complications and nonsurgical treatment.Patient symptoms include: vaginal pain, pelvic pain, groin pain, perin pain, anal pain, rect pain, pain inter, inab inter, off vag dis, incont not pres, rec incont, aggrav incont.Nonsurgical treatments: the patient was treated with pain medication for the treatment of: help with pelvic muscle.The patient was treated with other medication (please specify).The patient was treated with physiotherapy treatment (including pelvic floor exercises or training).
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