MalfunctionOTN
ADVANTAGE ULTRA SYSTEM
Received Jun 22, 2026 · Event occurred Jun 5, 2026
Report 25576780 · MDR key 25576780
Device
Generic name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retr
Manufacturer
Boston Scientific CorporationModel number
M0068502060Catalog number
M0068502060
Lot number
36363615
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
SURGEON WENT TO INSERT THE SLING AND SAID IT WAS FAULTY. DID NOT SPECIFY AS TO WHY IT WAS FAULTY.