MAUDE Adverse Event Report: UROPLASTY, LLC MACROPLASTIQUE IMPLANTS; AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

Model Number MPQ-2.5

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528)

Patient Problems Incontinence (1928); Urinary Tract Infection (2120)

Event Type  malfunction  

Manufacturer Narrative

Uroplasty is conservatively reporting each occurrence of this malfunction as a separate mdr based on the lack of information surrounding the incident, as well as the potential for the device to require explantation.The incidents were reported together directly to the (b)(6) and the reporter wished to remain anonymous.Uroplasty has contacted the distributor multiple times in an attempt to acquire additional information that could aid in performing an investigation, however due to privacy laws in (b)(6), very limited information on the actual incidents has been made available.Based on the information we were able to obtain, uroplasty is unable to discern what the potential cause of the erosion of the bulking agent is, however should further information be made available, we plan to update this report accordingly.

Event Description

Three patients in (b)(6) presented with potential complications possibly related to prior implantation of macroplastique.All three patients had macroplastique implanted years earlier; the subject of this report had two injections: one in 1998 and the second in 2007.The patients presented with recurrent incontinence and urinary tract infections.The reporter noted that the bulking material was said to have been exposed/eroded through the epithelium of the bladder neck and/or urethra.The doctor attempted to remove the material, however if was said the macroplastique was impossible to remove.

• Brand Name: MACROPLASTIQUE IMPLANTS
• Type of Device: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• 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: 8143732
• MDR Text Key: 130030500
• Report Number: 3002647932-2018-00010
• Device Sequence Number: 1
• Product Code: LNM
• UDI-Device Identifier: 08717591240266
• UDI-Public: 08717591240266
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P040050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2018

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: Health Professional
• Device Model Number: MPQ-2.5
• Device Catalogue Number: MPQ-2.5
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2018
• Initial Date FDA Received: 12/07/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention