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

Model Number MPQ-2.5 MACROPLASTIQUE 2.5CC

Device Problem Material Erosion (1214)

Patient Problem Failure of Implant (1924)

Event Date 09/23/2022

Event Type  Injury  

Event Description

Macroplastique bulking agent injection eroded into urethra.

• Brand Name: MACROPLASTIQUE IMPLANTS
• Type of Device: BULKING AGENT
• Manufacturer (Section D): UROPLASTY, LLC; 5420 feltl rd; minnetonka MN 55343
• Manufacturer (Section G): MINNETONKA; 5420 feltl rd; minnetonka MN 55341
• MDR Report Key: 15663132
• MDR Text Key: 302333202
• Report Number: 3017448360-2022-00011
• Device Sequence Number: 1
• Product Code: LNM
• UDI-Device Identifier: 08717591240266
• UDI-Public: 08717591240266
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 10/24/2022

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 Model Number: MPQ-2.5 MACROPLASTIQUE 2.5CC
• Device Catalogue Number: MPQ-2.5
• Device Lot Number: B16H2304
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/23/2022
• Initial Date Manufacturer Received: 09/23/2022
• Initial Date FDA Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1