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 03/10/2015

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted based upon fda feedback.

Event Description

Physician reported a patient experiencing what appeared to be a vaginal cyst.The physician stated that the patient received a macroplastique implant from another physician over a year and a half earlier and had a normal post-op.Two months prior the patient came to the physician stating she could feel the bulge.Upon examination the doctor could see what appeared to be a cyst.The cyst was removed and pathology reports determined the cyst was macroplastique.

• 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 ; 9524296161
• MDR Report Key: 6031294
• MDR Text Key: 57568018
• Report Number: 3002647932-2016-00003
• 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: health professional
• Reporter Occupation: Physician
• 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?: 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: 03/10/2015
• 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): Required Intervention
• Patient Age: 60 YR