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 Date 11/23/2015

Event Type  No Answer Provided  

Manufacturer Narrative

This report is being submitted based upon fda feedback.

Event Description

The patient contacted uroplasty to report that since receiving macroplastique treatment on (b)(6) 2015, she had been experiencing ongoing symptoms including a slight burning, some bleeding and heavy pressure in the urethral area.The patient was treated for uti but the symptoms did not resolve.Uroplasty reached out the physician to obtain additional information.The physician explained the patient had the procedure for mixed incontinence improved but not adequately controlled by anti-cholinergic therapy.The patient initially noted marked improvement but for the past month has had frequency and dysuria like symptoms.Uroplasty has since reached out to both the patient and physician to see if further medical treatment/intervention has occurred but no response has been received.If response or further infomration is received, uroplasty will submit a follow-up report.

• 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: 6031314
• MDR Text Key: 57552348
• Report Number: 3002647932-2016-00005
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• PMA/PMN Number: P040050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/14/2016

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
• Device Operator: Health Professional
• Device Model Number: MPQ-2.5
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2016
• Initial Date FDA Received: 10/14/2016
• 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 Outcome(s): Other
• Patient Age: 35 YR