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

Model Number 519650

Device Problem Break (1069)

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

Event Date 11/17/2022

Event Type  malfunction  

Event Description

Mesh pulled out from anchor.Surgeon able to retrieve pieces and successfully remove from patient.New working device implanted.No harm to patient and broken device was returned to manufacturer.Fda safety report id #(b)(4).

• Brand Name: ALTIS IMPLANTABLE MESH
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEM
• Manufacturer (Section D): COLOPLAST MANUFACTURING US, LLC.
• MDR Report Key: 15855816
• MDR Text Key: 304332029
• Report Number: MW5113447
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• 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: 11/18/2022

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 Model Number: 519650
• Device Catalogue Number: 519650
• Device Lot Number: 8003886
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female