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

Model Number 5002041022

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Urinary Retention (2119)

Event Date 09/22/2018

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) patient experienced perineal and scrotal pain after virtue procedure.Date of procedure: (b)(6) 2018.Date of onset event: (b)(6) 2018.Description of the event: permanent scrotal and perineal pain.No treatment.Status of the event: on (b)(6) 2018 (1st postoperative visit), patient had still pain (device still implanted).According to the investigator, the event is related to the procedure.This patient had a urinary retention after surgery ((b)(6) 2018).He had indwelling drainage during 7 days.This event was resolved on (b)(6) 2018.

• 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: 8181623
• MDR Text Key: 130920948
• Report Number: 2125050-2018-00884
• 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
• Type of Report: Initial
• Report Date: 12/13/2018

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: Health Professional
• Device Model Number: 5002041022
• Device Catalogue Number: 500204
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/23/2018
• Initial Date FDA Received: 12/19/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 75