MAUDE Adverse Event Report: UROPLASTY, LLC MACROPLASTIQUE IMPLANTS; AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

Model Number MPQ-2.5

Device Problem Material Erosion (1214)

Patient Problems Incontinence (1928); Pain (1994); Foreign Body In Patient (2687); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Some of the macroplastique material was removed when removing the bladder stone which occurred at the site of implantation.Per conversations with the initial reporter (dr.(b)(6)), most of the macroplastique material still remains in the patient.

Event Description

A female patient received macroplastique injections in 2013, having previously undergone midureteral mesh sling without improvement in her urinary incontinence.She presented recently with a 12 month history of progressive "vaginal" pain, especially following voiding.She was found on cystoscopy to have a bladder stone adherent to eroded material (macroplastique) at her right bladder neck.The bladder stone was treated endoscopically with a holmium laser, and some of the macroplastique implant was pulled out with the use of endoscopic grasping forceps.Most of the macroplastique was left behind.

• Brand Name: MACROPLASTIQUE IMPLANTS
• Type of Device: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): UROPLASTY, LLC; 5420 feltl road; minnetonka MN 55343
• Manufacturer (Section G): UROPLASTY, LLC; 5420 feltl road; minnetonka MN 55343
• Manufacturer Contact: nicole boser ; 5420 feltl road; minnetonka, MN 55343 ; 9524266141
• MDR Report Key: 7847007
• MDR Text Key: 119650074
• Report Number: 3002647932-2018-00007
• Device Sequence Number: 1
• Product Code: LNM
• UDI-Device Identifier: 08717591240266
• UDI-Public: 08717591240266
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/05/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: MPQ-2.5
• Device Catalogue Number: MPQ-2.5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2018
• Initial Date FDA Received: 09/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR