MAUDE Adverse Event Report: COLOPLAST CORP. ALTIS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

Model Number	519650
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Altis sling string came apart when implanting it into the patient.All pieces removed and new sling opened and placed successfully.

• Brand Name: ALTIS
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
• Manufacturer (Section D): COLOPLAST CORP.; 1601 w river rd n; minneapolis MN 55411
• MDR Report Key: 25650024
• Report Number: 25650024
• Device Sequence Number: 13210062
• Product Code: PAH
• UDI-Device Identifier: 05708932467407
• UDI-Public: (01)05708932467407
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/15/2026
• Report Date (Section F): 06/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 519650
• Device Catalogue Number: 519650
• Device Lot Number: 10422197
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/29/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Female
• Date Report Sent to FDA: 06/15/2026