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

Model Number 5002041022

Device Problem Insufficient Information (3190)

Patient Problem Incontinence (1928)

Event Date 06/29/2018

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.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

According to the available information, a (b)(6) year old patient experienced the aggravation of urinary incontinence after virtue procedure.Date of procedure: (b)(6) 2018; date of onset event: (b)(6) 2018.Description of the event: urinary symptoms.Aggravation of stress urinary.Incontinence : before virtue implantation, patient had pad test=20gr.On (b)(6) 2018 (1st postoperative visit), pad test was 30gr.Patient dissatisfied.Treatment: virtue revision on (b)(6) 2018 and physical rehabilitation.Status of the event: resolved on (b)(6) 2018 (device still implanted).According to the investigator, the event is related to the virtue sling.

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the investigation.The device remains implanted.Without the benefit of analyzing the device, quality cannot confirm any observations and cannot comment on the condition of the device.If the device becomes available, or additional information is received, quality will re-evaluate this complaint in accordance to procedures.However, because quality's examination may not conclusively confirm or disprove the report of stress urinary incontinence, quality accepts the physician's observations.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.A review of the complaint history database revealed no significant trends for lot 5537112.Review of nonconforming reports revealed no nonconformance's for this lot.No capas are associated with this lot.

• Brand Name: VIRTUE 2
• 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: stephanie perryman ; 1601 west rivier road north; minneapolis, MN 55411 ; 6124345685
• MDR Report Key: 8189368
• MDR Text Key: 131153297
• Report Number: 2125050-2018-00898
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• PMA/PMN Number: K113496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 01/21/2019

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
• Device Lot Number: 5537112
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/23/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 11/23/2018
• Supplement Dates FDA Received: 01/28/2019
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR