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 04/12/2015

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted based upon fda feedback.

Event Description

A patient presented to her physician what was described as a migration of the macroplastique (mpq) implant.Upon inspection the mpq had migrated near her vulva and was surgically removed.Two masses roughly the size of quail eggs were removed.The patient had received the mpq implant approximately 3 years previously during a routine procedure with no complications.

• 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: 6031298
• MDR Text Key: 57554562
• Report Number: 3002647932-2016-00004
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P040050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• 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: 04/12/2015
• 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