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

Model Number 5002041022

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 07/03/2020

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.Once our evaluation is complete, a follow-up report will be submitted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Device is still implanted.

Event Description

According to the available information, though not verified, a (b)(6) year old patient experienced perineal pain after virtue procedure.Date of procedure: (b)(6) 2020.Permanent perineal pain for 5 days.Treatment: analgesic with weak opioids.Date of resolution: (b)(6) 2020.According the investigator, the events are related to the procedure (device is still implanted).

Event Description

This follow-up mdr is created to document the additional event information received for record (b)(6).According to the available information the date of the virtue procedure was (b)(6) 2020.Information received indicated: ¿a 66-year old patient experienced perineal pain after virtue procedure.Permanent perineal pain during 15 days.Treatment: analgesic with weak opioids date of resolution: (b)(6) 2020.According the investigator, the events are related to the procedure (device is still implanted).No components were received for evaluation as the device remains implanted.As examination of the components may not conclusively confirm or disprove the report of pain quality accepts the physician¿s observations as to the reason for surgical intervention.A review of the complaint history database revealed no trends for this lot.Review of nonconforming reports revealed no nonconformance¿s for this lot.No capas are associated with this lot.No patient injury was reported.

Manufacturer Narrative

Based on the available information, the reported complaint is identified in the risk management documentation and reviewed routinely with management to monitor complaint trends as part of post market surveillance.No corrective action is required at this time.

• Brand Name: VIRTUE MALE SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 10806825
• MDR Text Key: 215263383
• Report Number: 2125050-2020-01068
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5002041022
• Device Catalogue Number: 500204
• Device Lot Number: 6996095
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 11/08/2020
• Supplement Dates Manufacturer Received: 10/09/2020
• Supplement Dates FDA Received: 12/17/2020
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 81