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

Model Number 5002041400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Incontinence (1928); Pain (1994); Discomfort (2330)

Event Type  Injury  

Event Description

As reported to coloplast though not verified, the patient was implanted with virtue sling.Later the patient experienced severe pain and discomfort and urinary incontinence was exacerbated.Patient was advised that the mesh was enmeshed with scar tissue and virtually impossible to remove.In addition to physical pain, patient has suffered loss of ability to perform sexual and substantial emotional and mental anguish.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information containted in this report.Device not returned, still implanted.

• Brand Name: VIRTUE
• Type of Device: MESH, SURGICAL, MALE
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road n; minneapolis MN 55411
• Manufacturer Contact: leeanne swiridow ; 1601 west river road n; minneapolis, MN 55411 ; 6123024945
• MDR Report Key: 4825203
• MDR Text Key: 17331437
• Report Number: 2125050-2015-00055
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• PMA/PMN Number: K1113496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2015

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 Model Number: 5002041400
• Device Catalogue Number: 50020
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/12/2015
• Initial Date FDA Received: 06/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2010
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR