BOSTON SCIENTIFIC - MARLBOROUGH SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
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Model Number M0068507000 |
Device Problem
Positioning Failure (1158)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 08/23/2017 |
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.The complainant indicated that the device is implanted 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 mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that a solyx sis system device was implanted during an anterior repair/sling/posterior repair procedure performed on (b)(6) 2017.According to the complainant, during procedure, the physician had difficulty releasing the mesh carrier from the shaft tip to the patient's right side.In addition, the physician stated that there was a lot of bleeding.This was treated with suction, raytex, and some floseal.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
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