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
Pain (1994); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505)
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Event Date 04/10/2013 |
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 a uphold implant and a advantage implant were implanted into the patient on (b)(6) 2013.The patient experienced complications and nonsurgical treatment.Patient symptoms include: vaginal pain; pelvic pain; pain inter; diff bowel; psych; nonsurgical treatments: the patient was treated with pain medication: various painkillers for the treatment of: help ease pain.Treatment duration: 12 months.The patient was treated with physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: to help pain.Treatment duration: 3mo ths.The patient was treated with physiotherapy treatment (including pelvic floor exercises or training).
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Search Alerts/Recalls
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