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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Micturition Urgency (1871); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Intermenstrual Bleeding (2665); Dyspareunia (4505)

Event Type  Injury  

Event Description

According to the available information, on or about (b)(6) 2022, patient underwent a surgical procedure to treat stress urinary incontinence during which a coloplast altis single incision sling system was implanted.The patient has subsequently suffered complications associated with the pelvic mesh product, including, mesh erosion, bleeding, infections, pelvic floor disfunction, pelvic pain, vaginal pain, dyspareunia, urinary urgency problems, scarring, permanent disfigurement, and difficulty with daily activities, which ultimately required surgical intervention and removal of mesh on (b)(6) 2023.

• 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: 18374278
• MDR Text Key: 331119013
• Report Number: 2125050-2023-01628
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 05708932467407
• UDI-Public: 05708932467407
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 519650
• 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
• Patient Outcome(s): Required Intervention