MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER

Catalog Number 519650

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 02/12/2024

Event Type  malfunction  

Event Description

According to the available information, the anchor releases immediately without force during implantation.This error occurred 3 times in a row during the procedure utilizing 3 distinct devices from the same lot.No adverse effects to the patient were reported.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18867461
• MDR Text Key: 337422957
• Report Number: 2125050-2024-00381
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 05701780274807
• UDI-Public: 5701780274807
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• 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: 9066451_5196504022
• Is the Reporter a Health Professional?: Yes
• Date Device Manufactured: 08/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1