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

Model Number MPQ-2.5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

This report is being sent based upon a literature review of images in urogynecology, doi 10.1007/s00192-016-3120-7.Uroplasty has reached out to the doctor for more information and will submit a follow-up should more information become available.

Event Description

A female patient received macroplastique for stress urinary incontinence.After 6 months, the patient noted a suburethral mass.The mass was asymptomatic, except the patient noted body image concerns related to the mass preventing initiation of a sexual relationship.The patient requested removal 18 months later.

• Brand Name: MACROPLASTIQUE IMPLANTS
• Type of Device: URETHRAL BULKING AGENT
• Manufacturer (Section D): UROPLASTY, LLC; 5420 feltl road; minnetonka MN 55343
• Manufacturer (Section G): UROPLASTY LLC; 5420 feltl road; minnetonka MN 55343
• Manufacturer Contact: jason skramsted ; 5420 feltl road; minnetonka, MN 55343 ; 9524266161
• MDR Report Key: 5966691
• MDR Text Key: 55270938
• Report Number: 3002647932-2016-00002
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/21/2016

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
• Device Operator: Health Professional
• Device Model Number: MPQ-2.5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2016
• Initial Date FDA Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR