BOSTON SCIENTIFIC CORPORATION OBTRYX II SYSTEM - HALO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number M0068505110 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Hemorrhage/Bleeding (1888)
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Event Date 12/06/2022 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that an obtryx ii system - halo was used during a cystoscopy and trans obturator sling (obtryx) procedure performed on (b)(6) 2017.On (b)(6) 2022, the patient underwent a vaginal mesh resection and repair of the anterior vaginal wall due to vaginal bleeding and mesh erosion.The patient tolerated the procedure well, and there were no apparent complications.
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Manufacturer Narrative
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Block b3: the exact event onset date is unknown.The provided event date of december 6, 2022, was chosen as the best estimate based on the revision date.Block h6: imdrf patient code e0506 captures the reportable event of vaginal bleeding.Imdrf patient code e2006 captures the reportable event of mesh exposure.Imdrf impact code f1905 captures the reportable event of vaginal mesh resection.
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Search Alerts/Recalls
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