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

Model Number 5002041400

Device Problem Insufficient Information (3190)

Patient Problem Numbness (2415)

Event Date 09/24/2013

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify this report.Device not returned.

Event Description

As reported to coloplast though not verified, patient was implanted with virtue male sling on (b)(6) 2014.On (b)(6) 2013 patient reported numbness around scrotum.No additional treatment was reported.

• Brand Name: VIRTUE MALE SLING SYSTEM WITH ALEXIS
• 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: tim crabtree-ra manager ; 1601 w. river road n; minneapolis, MN 55411 ; 6123024922
• MDR Report Key: 3660819
• MDR Text Key: 18567429
• Report Number: 2125050-2014-00157
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• PMA/PMN Number: K111881
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2014
• Device Model Number: 5002041400
• Device Catalogue Number: 5002041400
• Device Lot Number: 359920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other