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

Model Number 5002021022

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 06/04/2014

Event Type  Injury  

Event Description

As reported to coloplast though not verified, the patient was implanted with a coloplast virtue male sling.Later the patient experienced scrotal/penile pain during sexual intercourse and nocturnal erections.The patient was treated by antibiotics, ibuprofen and anti-inflammatory.The investigator has planned an hospitalization for new surgery (revision sling) on 27 january 2015 in order to remove the anterior part of the sling and place a new device.This was reported in the context of a clinical study.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Device remains implanted.

• Brand Name: VIRTUE
• 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 w. river road n.; minneapolis MN 55411
• Manufacturer Contact: leeanne swiridow - ra specialist ; 1601 w. river road n.; minneapolis, MN 55411 ; 6123024945
• MDR Report Key: 4337470
• MDR Text Key: 5222851
• Report Number: 2125050-2014-00439
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K101297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/17/2014

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: Other
• Device Expiration Date: 12/31/2016
• Device Model Number: 5002021022
• Device Catalogue Number: 50020
• Device Lot Number: 3970114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2014
• Initial Date FDA Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/06/2013
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other