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

Model Number	MPQ-2.5
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): UROPLASTY, LLC; 5420 feltl road; minnetonka MN 55343
• MDR Report Key: 11131046
• Report Number: 3002647932-2021-00001
• Device Sequence Number: 19400713
• Product Code: LNM
• UDI-Device Identifier: 08717591240266
• UDI-Public: 08717591240266
• Combination Product (Y/N): N
• PMA/510(K) Number: P040050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/07/2021

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
• Operator of Device: Health Professional
• Device Model Number: MPQ-2.5
• Device Catalogue Number: MPQ-2.5
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1