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

Model Number	MPQ-2.5
Health Effect - Clinical Codes	Incontinence (1928); Urinary Tract Infection (2120)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Uroplasty is conservatively reporting each occurrence of this malfunction as a separate mdr based on the lack of information surrounding the incident, as well as the potential for the device to require explantation.The incidents were reported together directly to the (b)(4) competent authority (tga) and the reporter wished to remain anonymous.Uroplasty has contacted the distributor multiple times in an attempt to acquire additional information that could aid in performing an investigation, however due to privacy laws in (b)(6), very limited information on the actual incidents has been made available.Based on the information we were able to obtain, uroplasty is unable to discern what the potential cause of the erosion of the bulking agent is, however should further information be made available, we plan to update this report accordingly.
Event or Problem Description
Three patients in (b)(6) presented with potential complications possibly related to prior implantation of macroplastique.Each patient had macroplastique implanted years earlier and presented with recurrent incontinence and urinary tract infections.For each patient, the reporter noted that the bulking material was said to have been exposed/eroded through the epithelium of the bladder neck and/or urethra.The doctor tried to explant the material, however if was said the macroplastique was impossible to remove.

• Brand Name: MACROPLASTIQUE IMPLANTS
• Common Device Name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): UROPLASTY, LLC; 5420 feltl road; minnetonka MN 55343
• MDR Report Key: 8143406
• Report Number: 3002647932-2018-00009
• Device Sequence Number: 1487537
• Product Code: LNM
• UDI-Device Identifier: 08717591240266
• UDI-Public: 08717591240266
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P040050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/06/2018

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
• Operator of Device: Health Professional
• Device Model Number: MPQ-2.5
• Device Catalogue Number: MPQ-2.5
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention