MAUDE Adverse Event Report: ABISS - ANALYTIC BIOSURGICAL SOLUTIONS ARIS TRANSOBTURATOR SLING; FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER

Model Number 5195101000

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

Patient Problems Erosion (1750); Emotional Changes (1831); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Fungal Infection (2419); Hematuria (2558); Dysuria (2684); Dyspareunia (4505); Urinary Incontinence (4572); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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, the patient with this device experienced mesh erosion, recurrent infections of multiple origins.Additionally, it was noted, the patient experienced worsening urination, chronic pain, scarring, inflammation, painful intercourse.The device was explanted.It is also noted that the patient will continue to require healthcare and services and medical related expenses.The patient has also suffered and continues to suffer mental anguish, diminished capacity for the enjoyment of life, and chronic and debilitating pain.

Event Description

Additional information received on 2/19/2023 indicates that the patient experienced urinary incontinence, funglal infection, hematuria and was hospitalized at an earlier date.

Manufacturer Narrative

Correction: item number, catalogue number, udi number.

Event Description

Additional information received on 9/29/2023 states the patient is also experiencing dysuria.

Manufacturer Narrative

Correction: item number.

• Brand Name: ARIS TRANSOBTURATOR SLING
• Type of Device: FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER
• Manufacturer (Section D): ABISS - ANALYTIC BIOSURGICAL SOLUTIONS; 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: 13560560
• MDR Text Key: 285829458
• Report Number: 2125050-2022-00150
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/20/2024

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: 04/16/2016
• Device Model Number: 5195101000
• Device Catalogue Number: 51951
• Device Lot Number: AL050037_5195102400
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2022
• Initial Date FDA Received: 02/18/2022
• Supplement Dates Manufacturer Received: 02/19/2023; 09/29/2023; 09/29/2023
• Supplement Dates FDA Received: 04/21/2023; 10/05/2023; 03/20/2024
• Date Device Manufactured: 08/04/2011
• 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: 56 YR
• Patient Sex: Female