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

Model Number MPQ-2.5

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888)

Event Type  malfunction  

Manufacturer Narrative

This incident is being reported as the literature stated that macroplastique was removed in addition to the caruncle.Authors of the report state that is suspected that the caruncle dragged the macroplastique material out through the urethral meatus which is why it was present in excised material.It is unclear if all macroplastique was removed.

Event Description

This incident was published in a journal article.A patient with a background os stress urinary incontinence underwent numerous pelvic surgeries including colposuspension, tension-free vaginal tape (tvt) and macroplastique.She developed bleeding from a 3cm urethral caruncle, which did not improve with vaginal oestrogens.She proceeded to have a surgical excision of the caruncle.Histology revealed a foreign material with surrounding foreign-body-type multinucleate giant cell reaction.The foreign material was compatible with macroplastique meaning that some macroplastique was removed as part of the excision of the caruncle.

• 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: 11131046
• MDR Text Key: 227007133
• Report Number: 3002647932-2021-00001
• Device Sequence Number: 1
• Product Code: LNM
• UDI-Device Identifier: 08717591240266
• UDI-Public: 08717591240266
• Combination Product (y/n): N
• PMA/PMN Number: P040050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• 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
• Date Manufacturer Received: 12/08/2020
• 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