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 Appears to Trigger Rejection (1524)

Patient Problems Inflammation (1932); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Prolapse (2475); Intermenstrual Bleeding (2665); Dyspareunia (4505)

Event Type  Injury  

Event Description

As reported to coloplast, though not verified, legal representative stated the patient with this device experienced severe pelvic pain, infections, bleeding, incomplete bladder emptying, foreign body reaction, scarring, inflammation, dyspareunia, vaginal vault prolapse, difficulty with daily activities and surgeries to explant the device.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

• 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: 17902279
• MDR Text Key: 325233905
• Report Number: 2125050-2023-01214
• Device Sequence Number: 1
• Product Code: PAH
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/25/2019
• Device Catalogue Number: 519650
• Device Lot Number: 4921161_5196502400
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2023
• Date Device Manufactured: 02/26/2016
• 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
• Patient Sex: Female