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); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)
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Event Date 09/27/2018 |
Event Type
Injury
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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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Event Description
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It was reported to boston scientific corporation that an uphold was implanted into the patient on (b)(6) 2017.An upsylon y-mesh was implanted into the patient on (b)(6) 2020.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep; back pain; vaginal pain; pelvic pain; groin pain; perin pain; anal pain; rect pain; thi pain; pain inter; inab inter; diff bowel; incont not pres; damage; psych; surgical interventions: on (b)(6) 2018 the patient underwent further surgery regarding the uphold implant for the following purpose: vagnial repair (removal of scar tissue).On (b)(6) 2019 the patient underwent further surgery regarding the uphold implant for the following purpose: removal of scar tissue.Nonsurgical treatments: the patient was treated with pain medication.The patient was treated with topical treatment (including oestrogen cream): oveston.The patient was treated with other (please specify) for the treatment of: vaginal pain, vaginal bleeding, mesh inflammed.Treatment duration: 10 days.The patient was treated with topical treatment (including oestrogen cream): tibolone.
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Search Alerts/Recalls
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