MAUDE Adverse Event Report: COLOPLAST A/S VIRTUE MALE SLING SYSTEM; SURGICAL MESH

Model Number 5002041022

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

Patient Problems Hematoma (1884); Pain (1994)

Event Date 01/06/2020

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa review.Devices met specification prior to release and no trends were noted.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 perineal hematoma after virtue procedure.Date of surgery: (b)(6) 2020, date of onset event: (b)(6) 2020, description of the event: perineal hematoma with pain occurred 2 days after the catheter removal.Treatment: ibuprofen and paracetamol status of the event: resolved on (b)(6) 2020.According to the investigator, this event is related to procedure.

• Brand Name: VIRTUE MALE SLING SYSTEM
• 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
• Manufacturer Contact: stephanie perryman ; 1601 west river road north; minneapolis, mn
• MDR Report Key: 9793755
• MDR Text Key: 188057661
• Report Number: 2125050-2020-00193
• 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: 03/03/2020

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
• Device Lot Number: 6949467
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 03/05/2020
• 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: 68 YR