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

Model Number 5002021022

Device Problem Insufficient Information (3190)

Patient Problem Urinary Retention (2119)

Event Date 06/19/2014

Event Type  Injury  

Event Description

As reported to coloplast though not verified, the patient was implanted with a coloplast virtue one region male sling.Later the patient experienced prolongation of hospitalization after implant of the device due to urinary retention requiring treatment.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Prolonged hospitalization due to urinary retention 2 days after initial implant.Device not returned.

• Brand Name: VIRTUE ONE SLING
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam-1; humlebaek 3050, dk
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 w. river road n.; minneapolis MN 55411
• Manufacturer Contact: angela kilian-head of ra ; 1601 w. river road n.; minneapolis, MN 55411 ; 6122874236
• MDR Report Key: 4113883
• MDR Text Key: 4925234
• Report Number: 2125050-2014-00405
• 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: 09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 03/31/2017
• Device Model Number: 5002021022
• Device Catalogue Number: 5002021022
• Device Lot Number: 4063324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/20/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization