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

Model Number MPQ-2.5

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erosion (1750); Urinary Tract Infection (2120)

Event Type  Injury  

Manufacturer Narrative

This report was originally reported to (b)(6) directly from the user facility.The user facility did not report the incident to the manufacturer.Several attempts have been made to gather information from the user facility, however they have not responded.We will continue to attempt to gather information.The incident appears to involve an erosion, however it is unclear what led to the erosion and/or the formation of the bladder stone.It is also not clear if the bladder stone contains bulking material device not available for return.

Event Description

The user facility reported to (b)(6) that a patient experienced erosion of the bladder mucosa with stone formation requiring removal.It was reported that the erosion of the bladder mucosa with stone formation was causing uti's, and pain.The bladder stone was removed.It does not appear that a serious deterioration of heath has occurred.It is unclear from the report whether or not the bladder stone contained the bulking material or how the device contributed to the incident, however the incident is being conservatively reported.

• 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: 6373116
• MDR Text Key: 68839613
• Report Number: 3002647932-2017-00001
• 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: foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/01/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2017
• Initial Date FDA Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention