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
Erosion (1750); Hemorrhage/Bleeding (1888); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Dyspareunia (4505)
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Event Date 02/01/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that an obtryx system - halo device was implanted into the patient during a procedure performed on (b)(6) 2015.After the procedure, the patient had been suffering from perineal, genital, anal pain and bleeding.The patient also experienced vaginal mesh erosion for which she underwent partial mesh excision.The patient had her mesh removed on (b)(6) 2017.Permanent neuropathic pain, compression of the pudendal nerve in the obturator foramen, and incapacity to have sexual intercourse are the current patient's conditions.
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Search Alerts/Recalls
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