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

Model Number MPQ-2.5

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

Several attempts were made to get more information regarding the incident.The incident is being reported as an adverse event since the mucosa was perforated, exposing the mpq, which may have let to the stone formation.At this point, we are considering the removal of the stone to be medical intervention to preclude permanent damage to a body structure or reforming bladder stones.

Event Description

Female patient who presented with urinary incontinence was initially treated via pubovaginal sling in 2005.In (b)(6) 2013, patient was given a suburethral injection of macroplastique (mpq) with good results and follow up through 2014.In (b)(6) 2017, the patient was referred back to her doctor for possible bladder stones - the patient reported mild bladder irritability and minor recurrent stress urinary incontinence (sui).The patient was found to have mucosa which had perforated exposing the mpq implant, and also had a bladder stone which developed on top of the exposed mpq implant.The patient underwent a cystolitholapaxy in (b)(6) 2017 to remove the bladder stones.It is unclear if the mpq implant was removed, or if other treatment was provided.

• 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: 7310369
• MDR Text Key: 101615830
• Report Number: 3002647932-2018-00004
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: MPQ-2.5
• Device Catalogue Number: MPQ-2.5
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/26/2017
• Initial Date FDA Received: 03/02/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR