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

Model Number MPQ-2.5

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

In a recent publication in the international urogynecology journal, it was noted that a female patient experienced migration of the mpq implant to her bladder.A postmenopausal woman had an mpq injection for incontinence in 2011.In 2014, she was diagnosed with bladder carcinoma and underwent transurethral resection of a bladder tumor.During a surveillance cystoscopy, an irregular area in the trigone of the bladder was noted, and resected by urology in 2016.Pathology of the mass returned as a foreign body giant cell reaction with refractile gel-like material consistent with mpq.

• Brand Name: MACROPLASTIQUE IMPLANTS
• Type of Device: URETHERAL 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: 7278187
• MDR Text Key: 100511729
• Report Number: 3002647932-2018-00002
• Device Sequence Number: 1
• Product Code: LNM
• UDI-Device Identifier: 08717591240266
• UDI-Public: 08717591240266
• 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: Other
• Type of Report: Initial
• Report Date: 02/15/2018

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: No Information
• Device Model Number: MPQ-2.5
• Device Catalogue Number: MPQ-2.5
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2018
• Initial Date FDA Received: 02/16/2018
• 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: N
• Patient Sequence Number: 1