MAUDE Adverse Event Report: COLOPLAST A/S ARIS TRANSOBTURATOR KIT; MESH

Model Number 5195501000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Urinary Frequency (2275); Kidney Infection (4502); Genital Bleeding (4507); Urinary Incontinence (4572)

Event Type  Injury  

Event Description

As reported to coloplast; although not verified.The patient's legal representative stated the patient was experiencing vaginal spotting and recurrent urinary tract infections and urinary frequency.On (b)(6) 2021 mesh exposure was observed.The mesh was excised under general anesthesia.On (b)(6) 2022.Recurrent stress urinary incontinence was observed and an altis sling was placed under general anesthesia.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Lot number 2096801.Portions of this event were previously submitted via alternative summary report (exception number e201405) submitted between august-september 2016; this report is intended to be a follow up report to submit additional information that has been received.

• Brand Name: ARIS TRANSOBTURATOR KIT
• Type of Device: MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 16956449
• MDR Text Key: 315528037
• Report Number: 2125050-2023-00597
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K050148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: 5195501000
• Device Catalogue Number: 519550
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female