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

Model Number 5195101000

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Emotional Changes (1831); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Abnormal Vaginal Discharge (2123); Dyspareunia (4505); Urinary Incontinence (4572)

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, the legal representative stated pelvic pain, dyspareunia, and mixed urinary incontinence.Patient had device explantation of three different devices under an unknown anesthesia.Another manufacturer's device was implanted under general anesthesia.

Manufacturer Narrative

Correction: medical device problem code.

Event Description

Additional information received on 3/17/2023 indicates the following: the patient has reported suffering from severe emotional pain and believes she will suffer apprehension of increased risk for injuries, infections, mental anguish, discharge, and corrective surgery to remove pieces of coloplast aris.

• 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: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 15445209
• MDR Text Key: 300122780
• Report Number: 2125050-2022-00950
• 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
• Report Date: 04/12/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 5195101000
• Device Catalogue Number: 519510
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 09/19/2022
• Supplement Dates Manufacturer Received: 03/17/2023
• Supplement Dates FDA Received: 04/12/2023
• 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: 38 YR