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); Fistula (1862); Unspecified Infection (1930)
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Event Date 03/28/2023 |
Event Type
Injury
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Manufacturer Narrative
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Block b3: the exact event onset date is unknown.The provided event date of march 28, 2023, was chosen as the best estimate based on the day of admission; the revision happened the day after.Block h6: imdrf patient code e2006 captures the reportable event of mesh erosion.Imdrf patient code e2314 captures the reportable event of colovaginal fistula.Imdrf patient code e1906 captures the reportable event of recurrent infections.Imdrf impact code f19 captures the reportable event of removal of the visible mid-urethral sling.
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Event Description
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It was reported to boston scientific corporation that an obtryx ii system - halo device was used during a total abdominal hysterectomy with right salpingectomy, panniculectomy, trans-obturator sling placement, and post-procedure performed on (b)(6) 2020.On (b)(6) 2023, the patient presented recurrent vaginal infections and a possible colovaginal fistula.A surgical procedure was performed in which approximately 2 cm of exposed mesh were identified on the left lateral aspect of the vagina.The patient underwent the removal of the visible mid-urethral sling.Additionally, during the procedure a fistula was identified tracking from the left lateral vagina to the buttock.There were no further patient complications reported.
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Search Alerts/Recalls
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