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

Model Number MPQ-2.5

Device Problem Malposition of Device (2616)

Patient Problems Urinary Retention (2119); Urinary Incontinence (4572)

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

This event is being reported as a reportable malfunction due to macroplastique being explanted.

Event Description

Patient had complaint of stress urinary incontinence, during exercises only, for 2 years after delivery.She started physical therapy with no success.Patient sought a physician and had a macroplastique procedure performed in (b)(6) 2019.No other procedures were performed at that time.Right after the procedure patient could not void at all and had to catheterize for a few days.Patient then started presenting difficulty to empty her bladder associated with a constant dribbling of urine.Two months after the macroplastique procedure a cystoscopy was performed and it showed the presence of the macroplastique implant on one side only.Another cystoscopy was performed in (b)(6) 2020 and it showed the same thing.Patient does not have any other pelvic floor symptoms.Patient had macroplastique removed in 2021.

• 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
• MDR Report Key: 11552491
• MDR Text Key: 245526983
• Report Number: 3002647932-2021-00002
• Device Sequence Number: 1
• Product Code: LNM
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2021

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
• Initial Date Manufacturer Received: 03/12/2021
• Initial Date FDA Received: 03/23/2021
• 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 Age: 33 YR