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

Model Number 5195501400

Device Problems Degraded (1153); Insufficient Information (3190)

Patient Problems Pain (1994); Deformity/ Disfigurement (2360); Prolapse (2475); Dyspareunia (4505); Sexual Dysfunction (4510); Urinary Incontinence (4572)

Event Type  Injury  

Manufacturer Narrative

This mdr is created as an additional follow-up to mdr record # 2125050-2020-00479, initially reported on 23-jun-2020 through esubmitter.This mdr is to reflect the additional information received.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Device not returned.

Event Description

As reported to coloplast, though not verified, additional information received on 04/03/2021.On (b)(6) 2016: transvaginal excision of ob tape sling, excision of anterior vaginal wall mesh performed for vaginal mesh exposure.On (b)(6) 2018 - harvest of rectus fascia graft, autologous fascial sling, cystoscopy, and transvaginal excision of mesh sling completed for sui.

• Brand Name: ARIS TRANSOBTURATOR KIT
• Type of Device: SURGICAL 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: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12297358
• MDR Text Key: 265784078
• Report Number: 2125050-2021-01123
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/09/2021

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: 5195501400
• Device Catalogue Number: 519550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2021
• Initial Date FDA Received: 08/09/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1