MAUDE Adverse Event Report: COLOPLAST A/S VIRTUE 2; SURGICAL MESH

Model Number 5002041022

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Incontinence (1928); Therapeutic Response, Decreased (2271)

Event Date 09/01/2015

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 of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the information received, renal and urinary disorder - worsening urinary incontinence.Hospitalization from (b)(6) 2016 in order to tighten the virtue sling (surgery on (b)(6) 2016).

• Brand Name: VIRTUE 2
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 5764989
• MDR Text Key: 48642352
• Report Number: 2125050-2016-00063
• 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,study,user facility
• Type of Report: Initial
• Report Date: 07/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 5002041022
• Device Catalogue Number: 5002041022
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/03/2016
• Initial Date FDA Received: 07/01/2016
• 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?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other