MalfunctionPAH
ALTIS
Received Mar 2, 2026 · Event occurred Dec 4, 2025
Report 24477502 · MDR key 24477502
Device
Generic name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Fema
Manufacturer
Coloplast Manufacturing Us, LlcModel number
519650Catalog number
519650
Lot number
9510795
Patient
88 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
FIRST SIDE PLACED SUCCESSFULLY AND SECOND SIDE CLEAT BROKE OFF IN THE SEATING PROCESS. SUBSTITUTE SLING ACQUIRED AND USED INSTEAD.