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 09/27/2016

Event Type  malfunction  

Manufacturer Narrative

This report is being filed based on the reported migration of the macroplastique.While there was no injury reported as a result of this migration, there is a potential for injury or surgical intervention in cases where migration occurs.In follow-up communications with the physician, he reported that he believed the bolus to still be encapsulated and the patient is reporting that she continues to be dry with no complaints of incontinence.The physician believes that the implant is continuing to work and provide bulking.The patient has received two implantations.The first on (b)(6) 2015 ((b)(4)) and the second on (b)(6) 2016 ((b)(4)).Device remains implanted in the patient.

Event Description

Patient was in the office for an established visit.She noticed a protrusion into her vaginal canal during intercourse.The dr.Ordered an mri and it shows a migration of the macroplastique.As this is not bothersome to the patient, the dr has elected to observe this.The patient will return in (b)(6) or will call if the issue becomes bothersome.

• 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: nicole boser ; 5420 feltl road; minnetonka, MN 55343 ; 9524266141
• MDR Report Key: 6096836
• MDR Text Key: 59748426
• Report Number: 3002647932-2016-00008
• 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: study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2016

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
• Device Lot Number: B15G1302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2016
• Initial Date FDA Received: 11/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 97