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

Model Number 5195501000

Device Problem Insufficient Information (3190)

Patient Problems Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Injury (2348); Prolapse (2475); 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 plaintiff severe pain with daily activities and intercourse, urinary disfunction, vaginal discharge and reoccurring stress incontinence.Plaintiff underwent a surgical procedure during which her physicians excised and removed the mesh due to lower urinary tract symptoms.Plaintiff has suffered, and continues to suffer, multiple, severe and painful personal injuries, including, but not limited to, vaginal prolapse, urinary incontinence, physical deformity, and the loss of the ability to perform sexually.

• Brand Name: ARIS TRANS-OBTURATOR
• 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 55411
• Manufacturer Contact: sarah o'gara ; 1601 west river road north; minneapolis, MN 55411 ; 6123578517
• MDR Report Key: 9535900
• MDR Text Key: 173227161
• Report Number: 2125050-2019-01190
• 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: 12/30/2019

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: 5195501000
• Device Catalogue Number: 519550
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/31/2019
• 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): Other