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); Pain (1994); Bowel Perforation (2668); Constipation (3274)
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Event Date 09/03/2013 |
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 was implanted into the patient on (b)(6) 2013.Uphold implant was also implanted into the patient on (b)(6) 2013.The patient experienced complications, further surgery, and nonsurgical treatment.Device 2 of 2 patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; pelvic pain; difficulties with bowel motions; other pain: low abdominal pain.Surgical interventions: on (b)(6) 2013 the patient underwent further surgery regarding the uphold implant under general anesthesia for the following purpose: emergency surgery for ruptured bowel (approx 1/3rd of bowel removed), plus hernia repair (with mesh).
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Search Alerts/Recalls
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