MAUDE Adverse Event Report: COLOPLAST A/S VIRTUE WITH ALEXIS; SURGICAL MESH

Model Number 5002041400

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Incontinence (1928); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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 of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the information received from patient's legal representation alleges that on or about (b)(6) 2014, a virtue sling was implanted in patient.Immediately following the surgery, plaintiff began experiencing severe pain in the area where the virtue device was implanted.Plaintiff also began experiencing severe pain in areas surrounding the virtue, including the scrotum and groin area.Following the implantation of the virtue device, plaintiff's urinary incontinence worsened.In addition, plaintiff now experiences pain while urinating and inability to completely his bladder, and severe nocturnal leakage.Following the implantation of the virtue device, plaintiff began experiencing severe sexual side effects, including pain, difficulty achieving and maintaining an erection, and severe issues related to climax.In an attempt to relieve the pain and discomfort caused by the virtue device, plaintiff has been prescribed pain medication treatment, which has been unsuccessful.Plaintiff has also undergone physical therapy.This treatment has been unsuccessful in relieving plaintiff's pain.

• Brand Name: VIRTUE WITH ALEXIS
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 5433915
• MDR Text Key: 38123712
• Report Number: 2125050-2016-00011
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• PMA/PMN Number: K101297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial
• Report Date: 02/12/2016

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: Physician
• Device Model Number: 5002041400
• Device Catalogue Number: 5002041400
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2016
• Initial Date FDA Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other