BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM - CURVED; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number M0068504000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Incontinence (1928); Pain (1994); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505)
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Event Date 02/04/2019 |
Event Type
Injury
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Manufacturer Narrative
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Patient identifier: (b)(6).The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.The complainant indicated that the device is not available for return; 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 a upsylon y-mesh implant was implanted into the patient on (b)(6) 2017 and a obtryx implant was implanted into the patient on (b)(6) 2017.The patient experienced complications, further surgery, and nonsurgical treatment.Device 2 of 2.Patient symptoms include: back pain; vaginal pain; pelvic pain; groin pain; perin pain; anal pain; thi pain; pain inter; diff bowel; rec incont; aggrav incont; psych.Surgical interventions: on (b)(6) 2019 the patient underwent further surgery under general anesthesia for the following purpose: posterior repair native tissue.
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