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); Constipation (3274); Dyspareunia (4505)
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Event Date 01/16/2016 |
Event Type
Injury
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Event Description
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Note: two boston scientific mesh devices were implanted into the same patient.This report pertains to the uphold.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) 2014.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; groin pain; perineum pain; painful intercourse; inability to have intercourse; difficulties with bowel motions; recurrent incontinence; aggravated incontinence surgical interventions: on (b)(6) 2016 the patient underwent further surgery regarding the advantage fit implant under general anesthesia for the following purpose: removal of vaginal sutures.
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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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