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

Catalog Number 50020

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Erosion (1750); Foreign Body Reaction (1868); Incontinence (1928); Pain (1994); Urinary Retention (2119); Injury (2348); Hematuria (2558); No Code Available (3191); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.(b)(4).

Event Description

As reported to coloplast though not verified, legal representative stated the patient suffered bodily injuries, including but not limited to, foreign body reaction, mesh protrusion, mesh erosion into the urethra requiring surgical removal, pelvic pain, bowel problems, urinary problems, testicular pain, scrotal sac pain and other injuries.

Manufacturer Narrative

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 patient experienced bodily injuries including but not limited to: foreign body reaction, mesh protrusion, mesh erosion into the urethra requiring surgical removal, pelvic pain, bowel problems, urinary problems, testicular pain, and scrotal sac pain.Additional information received further clarified the distal edge of the mesh eroded into the urethra.On (b)(6) 2018, the patient underwent excision of the right arm of the sling and partial removal of the left arm of the sling under general anesthesia.

Event Description

Complete patient medical records received on 11/7/2023 are currently in review by the clinical department.A follow-up report, if required, will be filed upon completion of the review.

Manufacturer Narrative

This complaint was investigated to the extent information was provided to coloplast.Due to the legal nature of this complaint and the device not being returned for evaluation a thorough investigation could not be executed.Should additional information become available, this file will be re-evaluated and updated according to current procedures.Complaints of this nature are monitored and captured within the product risk documentation.No further action or corrective action is required at this time.

Event Description

Additional information received on 1/24/2023 indicates the patient was experiencing the following symptoms: urinary retention, swelling, incontinence and hematuria.

• 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: 9857363
• MDR Text Key: 186103670
• Report Number: 2125050-2020-00260
• 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: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 50020
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2023
• 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): Required Intervention; Other
• Patient Age: 86 YR
• Patient Sex: Male