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

Model Number 5195512400

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

Patient Problems Micturition Urgency (1871); Pain (1994); Deformity/ Disfigurement (2360); Dyspareunia (4505); Sexual Dysfunction (4510); Urinary Incontinence (4572)

Event Type  Injury  

Manufacturer Narrative

This event was previously reported via asr on 24jun2019 (exemption number e2014015).This report is intended to be a follow up report to submit additional information that has been received.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

As reported to coloplast though not verified, the patient experienced severe pain with daily activities and intercourse, urinary incontinence, physical deformity, and the loss of ability to perform sexually.Partial excision of an unknown bladder sling took place.Additional information received further reported that on (b)(6) 2019 the patient was experiencing or had experienced pelvic pain and urge incontinence.Partial excision of the aris and partial excision of the unknown bladder sling took place, as well as periurethral muscle/fascia repair, cystoscopy, and urethroscopy.Intraoperative findings: no sling exposure or erosion.Two ridges palpated within the periurethral tissue where two prior slings were located (#1 blue synthetic sling located at distal urethral meatus close to external urethral meatus) (#2 white solid synthetic sling close to the uvj junction).

• 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: 11931517
• MDR Text Key: 254470740
• Report Number: 2125050-2021-00666
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 05708932442961
• UDI-Public: 05708932442961
• Combination Product (y/n): N
• PMA/PMN Number: K050148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/03/2021

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: Lay User/Patient
• Device Model Number: 5195512400
• Device Catalogue Number: 519551
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 06/03/2021
• 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: 59 YR