MAUDE Adverse Event Report: COLOPLAST A/S ARIS TRANS-OBTURATOR KIT; SURGICAL MESH

Model Number 5195511400

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Foreign Body Reaction (1868); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Abnormal Vaginal Discharge (2123); Discomfort (2330); Injury (2348); Blood Loss (2597); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

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, patient's legal representative stated serious bodily injuries, including but not limited to, foreign body reaction, low back pain, leg pain, pelvic pressure, infections, erosion, dyspareunia and other injuries.

Event Description

As reported to coloplast though not verified, additional information stated abnormal bleeding, urinary incontinence with vaginal discharge, vaginal spotting, pressure and vaginal odor, exposed mid urethral mesh with pelvic pain.Mesh removed.

Manufacturer Narrative

This follow-up was created to document the additional event and patient information.The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

• Brand Name: ARIS TRANS-OBTURATOR KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8761198
• MDR Text Key: 150117164
• Report Number: 2125050-2019-00532
• 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: other
• Type of Report: Initial,Followup
• Report Date: 04/28/2020

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: 5195511400
• Device Catalogue Number: 519551
• Device Lot Number: 2341333
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 07/03/2019
• Supplement Dates Manufacturer Received: 06/04/2019
• Supplement Dates FDA Received: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other