BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM - HALO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number M0068505000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Swelling (2091); Tissue Damage (2104); No Code Available (3191)
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Event Date 03/23/2010 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).(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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Event Description
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It was reported to boston scientific corporation that an obtryx transobturator mid-urethral sling system was implanted into the patient during a posterior vaginal repair and suburethral sling placement procedure on (b)(6) 2007 for the treatment of rectocele and urinary stress incontinence.On (b)(6) 2010, the patient underwent posterior vaginal wall repair and sacrospinous colpopexy.After the procedure, the patient complained of pain and was prescribed with endone.On (b)(6) 2016, the patient underwent an ultrasound due to pain in right-sided vaginal wall and lump in the area.Findings showed 6x7 cystic lesion in the right vaginal anterior to the mesh repair.
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Search Alerts/Recalls
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