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
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/26/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The lot number was reviewed for complaint trend, nonconforming (nc) report, and capa.No ncs, trend nor capas were identified in veeva.Devices met specification prior to release.
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Event Description
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According to the available information, the post assembly popped out of the dynamic anchor during tensioning of the sling [break].The sling was removed and replaced.
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Search Alerts/Recalls
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