MAUDE Adverse Event Report: UROPLASTY, LLC MACROPLASTIQUE IMPLANTS; INJECTABLE URETHRAL BULKING AGENT

Model Number MPQ-2.5 MACROPLASTIQUE 2.5CC

Device Problem Material Erosion (1214)

Patient Problem Failure of Implant (1924)

Event Date 05/16/2023

Event Type  malfunction  

Manufacturer Narrative

Erosion is a known risk of the device and listed as a precaution in the instructions for use as a possible post-treatment complication.

Event Description

Macroplastique eroded into the bladder neck bleb exposed causing nidus for infection and stone formation.

• Brand Name: MACROPLASTIQUE IMPLANTS
• Type of Device: INJECTABLE URETHRAL BULKING AGENT
• Manufacturer (Section D): UROPLASTY, LLC; 5420 feltl rd; minnetonka MN 55343
• Manufacturer (Section G): UROPLASTY, LLC; 5420 feltl rd; minnetonka MN 55343
• Manufacturer Contact: quois johnson ; 5420 feltl rd; minnetonka, MN 55343
• MDR Report Key: 17241113
• MDR Text Key: 318312702
• Report Number: 3017448360-2023-00013
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: MPQ-2.5 MACROPLASTIQUE 2.5CC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/19/2023
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1