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

Model Number MPQ-2.5

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Calcium Deposits/Calcification (1758)

Event Type  malfunction  

Manufacturer Narrative

This incident was found as part of a literature search and is being reported due to the removal of the macroplastique implant.

Event Description

A patient presented with a hisory of stress urinary incontinence and was treated with macroplastique.She presented with a (b)(6) supine test but had no evidence of vaginal erosion of the macroplastique.Patient underwent a retropubic midurethral sling but 8 months postoperatively was diagnosed with five utis in 7 months.Approximately 15 months after the sling procedure, a cystoscopy showed a calcified mass at the patient's bladder neck.Lithrotripsy was used on the calcified portion and revealed a softer material consistent with the bulking agent.A resectoscope was then used to remove the bulking agent.

• 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: 12274024
• MDR Text Key: 267025103
• Report Number: 3002647932-2021-00004
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MPQ-2.5
• Device Catalogue Number: MPQ-2.5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR