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

Model Number 5002041022

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

Patient Problems Incontinence (1928); Pain (1994); Hypoesthesia (2352)

Event Date 05/04/2018

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, a (b)(6) year old patient experienced pain and the urge incontinence after virtue procedure.Date of procedure: (b)(6) 2018.On (b)(6) 2018, patient reported the pain located in perineum and left lower limb.The pain was resolved before the 1 year visit but we don't have the date of resolution.On (b)(6) 2019 (1year visit after virtue surgery) patient reported de novo urge incontinence.Treatment with solifenacin.This event is still ongoing according the investigator, the events are related to the procedure (device is still implanted).

Event Description

Additional information indicated the patient has still urge incontinence treated by solifenacin.During the visit ((b)(6) 2020), patient reported the scrotum hypoesthesia, no treatment.According to investigator, it can be related to procedure.We don't have the information about the date onset of this event and the lot number.

• Brand Name: VIRTUE 2
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9205026
• MDR Text Key: 163139709
• Report Number: 2125050-2019-00873
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 07/01/2020

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: Health Professional
• Device Model Number: 5002041022
• Device Catalogue Number: 500204
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 10/17/2019
• Supplement Dates Manufacturer Received: 09/17/2019
• Supplement Dates FDA Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Weight: 83