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

Device Problem Insufficient Information (3190)

Patient Problems Incontinence (1928); Pain (1994); Tissue Damage (2104); Deformity/ Disfigurement (2360); Nervous System Injury (2689); No Information (3190); No Code Available (3191)

Event Date 12/21/2018

Event Type  Injury  

Manufacturer Narrative

The reason for "repair pelvic organs" is unknown."loss of ability to perform sexually".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 legal representative stated severe pain with daily activities and intercourse.Operations to locate and remove mesh, operations to attempt to repair pelvic organs, tissue, nerve damage, use of pain control and medications, injections into various areas of the pelvis, spine and vagina, operations to remove portions female genitalia, urinary incontinence, physical deformity and loss of ability to perform sexually.Sling removed.

• Brand Name: ARIS TRANSOBTURATOR KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis, mn
• Manufacturer Contact: stephanie perryman ; 1601 west river road north; minneapolis, mn
• MDR Report Key: 10222157
• MDR Text Key: 197788556
• Report Number: 2125050-2020-00475
• 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: other
• Type of Report: Initial
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention