MAUDE Adverse Event Report: COLOPLAST MANUFACTURING US, LLC. ALTIS COLOPLAST ALTIS SLING; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

Catalog Number 519650

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/25/2023

Event Type  Injury  

Event Description

Defective sling during gyn surgery coloplast, altis ref: 519650, batch code: 8710291, exp: 2025-10-28.

• Brand Name: ALTIS COLOPLAST ALTIS SLING
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
• Manufacturer (Section D): COLOPLAST MANUFACTURING US, LLC.
• MDR Report Key: 16832861
• MDR Text Key: 314289573
• Report Number: MW5117110
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/25/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 519650
• Device Lot Number: 8710291
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention