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

Model Number 5002001400

Device Problem Insufficient Information (3190)

Patient Problems Hematoma (1884); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Nerve Proximity Nos (Not Otherwise Specified) (2647)

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information, an abstract article - 29 patients were treated with a virtue mail sling.Total of 17 complications, which occurred in those 29 patients.Reported complications were: scrotal pain, acute urinary retention, perineal hematoma, fever, uti and neuropraxia.All but one patient were discharged on the first postoperative day.

• 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 west rivier road north; minneapolis MN 55411
• Manufacturer Contact: sarah o'gara ; 1601 west rivier road north; minneapolis, MN 55411 ; 6123578517
• MDR Report Key: 8552185
• MDR Text Key: 143134033
• Report Number: 2125050-2019-00319
• 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: company representative,litera
• Type of Report: Initial
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5002001400
• Device Catalogue Number: 500200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other