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

Lot Number 7060197

Device Problems Device Dislodged or Dislocated (2923); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 09/21/2020

Event Type  malfunction  

Event Description

As traction was applied to the anchor, the suture came out of the body of the mesh.It looked to be a manufacturing type defect.Fda safety report id# (b)(4).

• Brand Name: ALTIS GYN SINGLE INCISION MESH
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
• Manufacturer (Section D): COLOPLAST MANUFACTURING US, LLC ; minneapolis MN 55411
• MDR Report Key: 10579549
• MDR Text Key: 208525577
• Report Number: MW5096829
• Device Sequence Number: 1
• Product Code: OTN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2022
• Device Lot Number: 7060197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 55