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

Model Number	MPQ-2.5
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The issue was discovered through a routine literature search.Several attempts were made to reach the author for more information regarding the event, however no response was received.It was noted that the patient received several repeat treatments with mpq despite limited improvement in her symptoms.This, coupled with the patient's history, may indicate that she was a poor candidate for treatment.
Event or Problem Description
A (b)(6) year-old caucasian female first presented 20 years ago with bladder prolapse and genuine stress urinary incontinence (sui).After failing to improve on conservative management and colposuspension, she underwent a macroplastique (mpq) injection for persistent urodynamically confirmed sui.She experienced brief symptomatic improvement, but symptoms reoccurred within months, leading to three separate injections of mpq at six monthly intervals.Each of these injections had a similar outcome as previously, but after the final injection, her symptoms partially settled, but she experienced storage systems.Seven years ago, these storage systems worsened.A cystoscopy performed showed mucosal swellings with calcifications close to the bladder neck and the proximal urethra.The calcifications were resected, and histopathology showed foreign material without malignancy.The patient's sui did not deteriorate any further, however she developed urgency symptoms.Two years ago, patient was referred for non-visible haematuria with post-micturition pain.A cystoscopy revealed unhealthy areas close to the bladder neck that were resected.Histopathology showed only a foreign body reaction, and an ultrasound showed echogenic material in the bladder wall close to the bladder neck.

• Brand Name: MACROPLASTIQUE IMPLANTS
• Common Device Name: URETHERAL BULKING AGENT
• Manufacturer (Section D): UROPLASTY, LLC; 5420 feltl road; minnetonka MN 55343
• MDR Report Key: 7328022
• Report Number: 3002647932-2018-00003
• Device Sequence Number: 464341
• Product Code: LNM
• UDI-Device Identifier: 08717591240266
• UDI-Public: 08717591240266
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P040050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2018

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: 11/16/2017
• Initial Report FDA Received Date: 03/09/2018
• 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: 71 YR