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

Model Number 5196502400

Device Problems Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Urinary Tract Infection (2120); Hematuria (2558); Dysuria (2684)

Event Date 03/21/2022

Event Type  Injury  

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.

Event Description

As reported to coloplast, though not verified, legal representative stated the patient with this device had a specimen of exposed device noted in pathology.The patient had a diagnostic cystoscopy and anterior vaginal wall biopsy under general anesthesia for device exposure.Interoperative findings included an evaluation of the entire vagina that revealed no exposed device, no suture material poking or penetrating through and no areas of roughened edges.The site where the device was previously expelled is visualized and is healed appropriately.The urethra is well positioned and scarred appropriately in the usual manner expected for post-device anatomical placement.

Event Description

Additional information received on 2/4/2024 indicates that the patient also experienced a urinary tract infection, hematuria, and dysuria.

Manufacturer Narrative

Correction to device code.

• 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 (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 15839077
• MDR Text Key: 304079543
• Report Number: 2125050-2022-01282
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

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 Operator: Lay User/Patient
• Device Expiration Date: 10/25/2022
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 6977903_5196502400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 11/04/2022
• Supplement Dates FDA Received: 02/20/2024
• Date Device Manufactured: 11/04/2019
• 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 Age: 45 YR
• Patient Sex: Female