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

Model Number 5002021022

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Numbness (2415)

Event Type  Injury  

Event Description

As reported to coloplast though not verified, the patient was implanted with a coloplast virtue one sling.Later the patient experienced a numb scrotum, the sexual functions of evacuation are gone, pain and pinching.The patient was given injections for pain.Trammel shots are currently being given due to the pain.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.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: 4017291
• MDR Text Key: 20459202
• Report Number: 2125050-2014-00387
• 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
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 5002021022
• Device Catalogue Number: 5002021022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other