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); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505)
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Event Date 07/16/2010 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that a uphold was implanted into the patient on (b)(6) 2010.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: back pain; vaginal pain; pelvic pain; groin pain; perin pain; anal pain; pain inter; off vag dis; diff bowel; rec incont; psych; nonsurgical treatments: on (b)(6) 2010 the patient commenced pain medication: panadol/ibuprofen for the treatment of: pain.On (b)(6) 2006 the patient commenced psychological medication: volost for the treatment of: 150mg per night.On (b)(6) 2010 the patient commenced physiotherapy treatment (including pelvic floor exercises or training).On (b)(6) 2010 the patient commenced topical treatment (including oestrogen cream): anti-thrush cream.
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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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