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

Model Number	MPQ-2.5
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Event or Problem Description
In a recent publication in the international urogynecology journal it was noted that a patient experienced migration of the mpq implant into her vagina.A postmenoposal woman underwnt periurethral buling with mpq in 2014 and presented in 2015 complaining of a vaginal mass.Upon examination a firm 2-cm lateral periuretral mass was observed.The mass was excised and the patient reportedly healed well.Pathology of the mass returned as a foreign body giant cell reaction with refractile gel-like material consistent with mpq.

• Brand Name: MACROPLASTIQUE IMPLANTS
• Common Device Name: URETHRAL BULKING AGENT
• Manufacturer (Section D): UROPLASTY, LLC; 5420 feltl road; minnetonka MN 55343
• MDR Report Key: 7277998
• Report Number: 3002647932-2018-00001
• Device Sequence Number: 16719461
• Product Code: LNM
• UDI-Device Identifier: 08717591240266
• UDI-Public: 08717591240266
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/16/2018

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
• Operator of Device: No Information
• Device Model Number: MPQ-2.5
• Device Catalogue Number: MPQ-2.5
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1