MAUDE Adverse Event Report: COLOPLAST A/S ALTIS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEM

Model Number 519650

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 05/06/2022

Event Type  malfunction  

Event Description

Device was opened to the field and the surgeon attempted to use it, but it didn't work.Manufacturer response for bladder sling, coloplast (per site reporter).They are going to report an adverse event and give us a credit for the device.

• Brand Name: ALTIS
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEM
• Manufacturer (Section D): COLOPLAST A/S; 1601 west river road north; minneapolis MN 55411
• MDR Report Key: 14573170
• MDR Text Key: 293157727
• Report Number: 14573170
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/25/2022,05/24/2022

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: 8104590
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/25/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Sex: Female