BOSTON SCIENTIFIC - MARLBOROUGH ADVANTAGE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number M0068502000 |
Device Problem
Torn Material (3024)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/12/2017 |
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.(b)(4).The complainant indicated that the device 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 system was implanted during a mid-urethral sling procedure performed on (b)(6) 2017.According to the complainant, on (b)(6) 2017, the patient visited the physician due to recurrent urinary incontinence.It was then discovered that the mesh split about 3/4 of the width.The sling was removed and was replaced with a new sling.
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Search Alerts/Recalls
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