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); Pain (1994); Foreign Body In Patient (2687); No Code Available (3191)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): UROPLASTY, LLC; 5420 feltl road; minnetonka MN 55343
• MDR Report Key: 7847007
• Report Number: 3002647932-2018-00007
• Device Sequence Number: 2547758
• Product Code: LNM
• UDI-Device Identifier: 08717591240266
• UDI-Public: 08717591240266
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P040050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• 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: 08/14/2018
• Initial Report FDA Received Date: 09/05/2018
• 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
• Patient Age: 46 YR