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

Model Number 5002041022

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Urinary Retention (2119)

Event Date 09/17/2017

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 available information, patient experienced urinary retention 5 days after virtue surgery.Treatment : on (b)(6) 2017 : urinary drainage (indwelling foley catheter during 15 days), on (b)(6) 2017 : section of the device (without removal).Outcome of the event : resolved on (b)(6) 2017.Device still implanted in the patient on (b)(6) 2017.Since (b)(6) 2017, the patient does self-catherization.According to the centre, this event is related to the procedure.

Manufacturer Narrative

This follow up mdr was created to document the additional event information and lot number received.

Event Description

According to the available information, patient experienced urinary retention 5 days after virtue surgery.Treatment: on (b)(6) 2017 : urinary drainage (indwelling foley catheter during 15 days), on (b)(6) 2017: section of the device (without removal).Outcome of the event : resolved on (b)(6) 2017 device still implanted in the patient on (b)(6) 2017.Since (b)(6) 2017, the patient does self-catheterization.According to the centre, this event is related to the procedure.Additional information received indicated: on (b)(6) 2017, the patient had no fever under treatment (augmentin: amoxicillin / clavulanic acid).Removal of the catheter and removal of compression bandage.Pvr : 375 ml, miction: 500 ml.On (b)(6) 2017 evening, as no spontaneous miction, a catheter was placed again (the site thought that the bladder was a little bit hypotonic because of urinary retention episode).On (b)(6) 2017: removal of the catheter and again catheter placement: hospital discharge with catheter and analgesic (paracetamol 1g x 3 per day).On (b)(6) 2017: removal of the catheter but no spontaneous miction, so again indwelling catheterization.The site can't provide the date of removal of this catheter.On (b)(6) 2017: the patient was better.Resumption of spontaneous urination.Pvr around 100 ml.The patient was encouraged to continue self-catheterization for some time.On (b)(6) 2017: adverse event is considered resolved by the site.

• 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 river road north; minneapolis MN 55411
• Manufacturer Contact: stephanie perryman ; 1601 west river road north; minneapolis, MN 55411 ; 6123024983
• MDR Report Key: 7061067
• MDR Text Key: 92997522
• Report Number: 2125050-2017-00582
• 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: foreign,study,user facility
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

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: Physician
• Device Model Number: 5002041022
• Device Catalogue Number: 5002041022
• Device Lot Number: 5217721
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2017
• Initial Date FDA Received: 11/27/2017
• Supplement Dates Manufacturer Received: 09/20/2017
• Supplement Dates FDA Received: 03/19/2018
• 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
• Patient Age: 74 YR