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); Urinary Tract Infection (2120); Constipation (3274); Dyspareunia (4505)
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Event Date 02/01/2020 |
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 an uphold was implanted into the patient on (b)(6) 2015.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; other pain: constant ache in lower abdomen; painful intercourse; inability to have intercourse; difficulties with bowel motions; incontinence not present before implant; recurrent incontinence nonsurgical treatments: the patient was treated with pain medication.On (b)(6) 2020 the patient commenced other medication (please specify): keflex/augmentin/flagyl for the treatment of: antibiotics to treat constant utis.Treatment duration: ongoing; daily.On (b)(6) 2021 the patient commenced other (please specify) for the treatment of: to control utis.Treatment duration: ongoing; daily.
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Search Alerts/Recalls
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