BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Pain (1994); Discomfort (2330); Cramp(s) /Muscle Spasm(s) (4521); Unspecified Tissue Injury (4559)
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Event Date 08/30/2017 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that an uphold lite with capio slim device was used during an anterior repair with graft, cuff suspension with graft, and posterior repair procedure performed on (b)(6) 2017, for the treatment of recurrent prolapse with an estimated blood loss of 200 ml.On (b)(6) 2019, the patient underwent vaginal mesh excision and a cystoscopy procedure for the treatment of atrophic vaginitis and a sensation of pressure in the bladder area.Moreover, the patient presented with an extensive history of reconstructive pelvic floor surgery, who had complaints of pelvic pain and vaginal spotting in the setting of apical mesh exposure in the vagina and desired surgical management.She does have a history of chronic pain, including evidence of levator spasm on exam.She also reported that she experienced urinary urgency and bladder discomfort at times with a very full bladder.
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Manufacturer Narrative
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Date of event: date of event was approximated to (b)(6) 2017, the date the sling was implanted, as no event date was reported.This event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6), (b)(6) medical center, (b)(6), united states, phone number: (b)(6).The revision surgeon is: dr.(b)(6), (b)(6) medical center, (b)(6), united states.(b)(4).The complaint device is not expected to be returned for evaluation; 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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