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
Erosion (1750); 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 10/31/2012 |
Event Type
Injury
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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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Event Description
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It was reported to boston scientific corporation that an uphold prolapse repair mesh and an advantage fit sling were implanted into the patient on (b)(6) 2012.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); pelvic pain; groin pain; perineum pain; anal pain; other pain: lower stomach; painful intercourse; offensive vaginal discharge; difficulties with bowel motions; incontinence not present before implant; recurrent incontinence; aggravated incontinence; psychiatric injury.Surgical interventions: on (b)(6) 2012 the patient underwent further surgery regarding the advantage fit implant under general anesthesia for the following purpose: small revision prolapse surgery and a small fenton's procedure.Nonsurgical treatments: on (b)(6) 2012 the patient commenced pain medication: endone for the treatment of: pain relief for diverticular disease.Treatment duration: ongoing.On (b)(6) 2013 the patient commenced incontinence medication: gastrostop for the treatment of: bowel incontinence.Treatment duration: ongoing.The patient was treated with other medication (please specify).On (b)(6) 2013 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: help improve pelvic floor for incontinence.Treatment duration: ongoing.On (b)(6) 2013 the patient commenced topical treatment (including oestrogen cream): oestrogen cream.Treatment duration: on going.
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Search Alerts/Recalls
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