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

Model Number	MPQ-2.5
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Several attempts were made to get more information regarding the incident.The incident is being reported as an adverse event since the mucosa was perforated, exposing the mpq, which may have let to the stone formation.At this point, we are considering the removal of the stone to be medical intervention to preclude permanent damage to a body structure or reforming bladder stones.
Event or Problem Description
Female patient who presented with urinary incontinence was initially treated via pubovaginal sling in 2005.In (b)(6) 2013, patient was given a suburethral injection of macroplastique (mpq) with good results and follow up through 2014.In (b)(6) 2017, the patient was referred back to her doctor for possible bladder stones - the patient reported mild bladder irritability and minor recurrent stress urinary incontinence (sui).The patient was found to have mucosa which had perforated exposing the mpq implant, and also had a bladder stone which developed on top of the exposed mpq implant.The patient underwent a cystolitholapaxy in (b)(6) 2017 to remove the bladder stones.It is unclear if the mpq implant was removed, or if other treatment was provided.

• Brand Name: MACROPLASTIQUE IMPLANTS
• Common Device Name: URETHRAL BULKING AGENT
• Manufacturer (Section D): UROPLASTY, LLC; 5420 feltl road; minnetonka MN 55343
• MDR Report Key: 7310369
• Report Number: 3002647932-2018-00004
• Device Sequence Number: 119705
• Product Code: LNM
• UDI-Device Identifier: 08717591240266
• UDI-Public: 08717591240266
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P040050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/02/2018

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?: No
• Operator of Device: No Information
• Device Model Number: MPQ-2.5
• Device Catalogue Number: MPQ-2.5
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 03/02/2018
• 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: 64 YR