COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER
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Catalog Number 519650 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Micturition Urgency (1871); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Intermenstrual Bleeding (2665); Urinary Incontinence (4572)
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Event Type
Injury
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Manufacturer Narrative
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The lot number was reviewed for complaint trend, non-conforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no non-conforming reports or capas that were confirmed in veeva to be associated.
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Event Description
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According to the available information the device was explanted and due pain, mesh exposure, incontinence, uti and an infection.
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Search Alerts/Recalls
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