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

Model Number	MPQ-2.5
Health Effect - Clinical Codes	Erosion (1750); Incontinence (1928); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information was found during a routine literature search as an abstract.Uroplasty has been in contact with one of the abstract's authors, however no additional information has been provided to us at this time.
Event or Problem Description
A (b)(6) year old male with mild persistent stress urinary incontinence (sui) after a radical prostatectomy underwent elective intraureteral bulking agent injections.After the initial mild improvement, the sui progressed and the patient required 5 diapers a day.The patient subsequently had an artificial urinary sphincter (aus) placement with improvement of his leakage.Two years later, the patient represented with worsening sui despite normal aus function.Upon urethroscopy, it was discovered that the patient had urethral erosion with crystals that enveloped his cuff.These were found to be macroplastique type crystals during pathologic evaluation.Three additional procedures, including aus removal, open and endoscopic procedures were required to remove residual macroplastique crystals.

• Brand Name: MACROPLASTIQUE IMPLANTS
• Common Device Name: URETHERAL BULKING AGENT
• Manufacturer (Section D): UROPLASTY, LLC; 5420 feltl road; minnetonka MN 55343
• MDR Report Key: 7650146
• Report Number: 3002647932-2018-00006
• Device Sequence Number: 125884
• Product Code: LNM
• UDI-Device Identifier: 08717591240266
• UDI-Public: 08717591240266
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2018

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 Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 06/29/2018
• 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: Other
• Patient Age: 67 YR