BOSTON SCIENTIFIC - MARLBOROUGH ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number M0068502110 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Internal Organ Perforation (1987)
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Event Date 09/22/2016 |
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.However, the complainant reported that the device was not expired.(b)(4).The complainant indicated that the device is disposed and will not 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 advantage fit system was implanted during mid urethral sling placement procedure on (b)(6) 2016.According to the complainant, post procedure, the patient experienced nausea and was brought back to the emergency room.It was then determined that the bowel was perforated.On (b)(6) 2016, surgery was performed to remove the mesh from the bowel.
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Search Alerts/Recalls
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