BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Incontinence (1928); Pain (1994); Injury (2348)
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Event Date 01/01/2013 |
Event Type
Injury
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Manufacturer Narrative
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The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).Other: tga device incident report reference no (b)(4); submitted to tga (therapeutic goods administration) by a healthcare professional/user.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 tape was implanted into the patient during a procedure performed in 2013.According to the complainant, after the implantation, the patient has experienced pain, bladder dysfunction and various other medical illnesses due to "mesh disease." boston scientific has been unable to obtain additional information regarding the event to date.
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Search Alerts/Recalls
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