BOSTON SCIENTIFIC CORPORATION UPHOLD VAGINAL SUPPORT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number 831-708 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Constipation (3274); Dyspareunia (4505); Insufficient Information (4580)
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Event Date 10/20/2021 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that a uphold implant and a upsylon y-mesh implant were implanted into the patient on an unspecified date.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep; back pain; vaginal pain; pelvic pain; groin pain; rect pain; thi pain; inab inter; off vag dis; diff bowel; incont not pres; rec incont; aggrav incont; oth pain: urirytrack infections.Surgical interventions: on an unspecified date the patient underwent further surgery regarding the upsylon y-mesh implant for the following purpose: to have the mesh removed as it impacted the bladder and caused errosion and pain that is why i had to have it removed i sufferd lots of pain and bleeding.Nonsurgical treatments: on (b)(6) 2021 the patient commenced pain medication: cefalexin sandoz 500mg for the treatment of: for treatment of urinrey track infection.Treatment duration: 5 days.On (b)(6) 2021 the patient commenced incontinence medication: curam duo amoxicillin tri hydrate 500mg clavulanic 125 mg for the treatment of: as the other medication was not the right medication to treat the infection.Treatment duration: 5days.
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Manufacturer Narrative
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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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