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

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

Patient Problems Erosion (1750); Calcium Deposits/Calcification (1758)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

This incident is being reported to fda as the implant required removal.Additional information regarding the patient is currently being sought out - any new information will be submitted to fda as a follow-up report.This report is being submitted after the 30 day window due to issues obtaining a signing certificate.

Event Description

Patient reported receiving macroplastique implants in 2005.In 2019, a ct scan was performed and a mass was discovered in the patient's bladder at the urethral neck.A cystoscopy of the bladder was performed revealing calcification at the site of the implant.A laser lithoplasty in 2019 was done to remove the calcification, however one month later additional calcification at this site was reported.An mri with and without contrast was performed and in 2020, robot assisted surgery was done to remove the macroplastique implant, calcification and part of the eroded bladder wall.Patient is currently incontinent waiting for a sling procedure to be performed.

• Brand Name: MACROPLASTIQUE IMPLANTS
• Type of Device: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): UROPLASTY, LLC; 5420 feltl road; minnetonka, mn
• Manufacturer (Section G): UROPLASTY, LLC; 5420 feltl road; minnetonka, mn
• Manufacturer Contact: nicole boser ; 5420 feltl road; minnetonka, mn ; 4266141
• MDR Report Key: 10397073
• MDR Text Key: 238331349
• Report Number: 3002647932-2020-00001
• Device Sequence Number: 1
• Product Code: LNM
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2020

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 08/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention