MAUDE Adverse Event Report: COLOPLAST A/S VIRTUE MALE SLING SYSTEM; MALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER

Model Number 5002041400

Device Problem Insufficient Information (3190)

Patient Problems Emotional Changes (1831); Foreign Body Reaction (1868); Pain (1994); Scar Tissue (2060); Injury (2348); Disability (2371); No Information (3190); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.(b)(4).Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

As reported to coloplast though not verified, the legal representative stated foreign body reaction, significant scar tissue, constant perineal pain, surgical excision of the sling, artificial urinary sphincter (aus) placement, back pain from being unable to sit properly, urinary problems and other injuries, disability, impairment, loss of enjoyment of life and sustained permanent injury.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

Additional information received further reported that the sling looked like it had been placed directly on the proximal penile urethra.

Event Description

Complete patient medical records received on (b)(6) 2023 are currently in review by the clinical department.A follow-up report, if required, will be filed upon completion of the review.

Event Description

Additional information received on (b)(6) 2024 indicates that the patient underwent excision of the sling on (b)(6) 2019.

• Brand Name: VIRTUE MALE SLING SYSTEM
• Type of Device: MALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis, mn
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411 ; 6128651177
• MDR Report Key: 10173147
• MDR Text Key: 200623910
• Report Number: 2125050-2020-00434
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2014
• Device Model Number: 5002041400
• Device Catalogue Number: 50020
• Device Lot Number: 3369185_5002041400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2012
• 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): Hospitalization; Disability; Required Intervention; Other
• Patient Age: 67 YR
• Patient Sex: Male