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 10/26/2021 |
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 advantage implant were implanted into the patient on (b)(6) 2021.The patient experienced complications 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; rec incont; aggrav incont; damage; psych.Nonsurgical treatments: the patient was treated with pain medication: tapendol for the treatment of: treat pain.Treatment duration: unknown.The patient was treated with psychological medication.On (b)(6) 2021 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: to help manage symptoms of pain and discomfort.Treatment duration: 6 sessions.
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Manufacturer Narrative
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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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Search Alerts/Recalls
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