MAUDE Adverse Event Report: UROPLASTY, LLC MACROPLASTIQUE IMPLANTS; URETHERAL BULKING AGENT

Model Number	MPQ-2.5
Health Effect - Clinical Codes	Erythema (1840); Muscular Rigidity (1968); Pain (1994); Reaction (2414)
Date of Event	09/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no clear linkage at this point between the patient's implantation of mpq and her reaction, however the patient has requested a sample of the product so it can be used to either identify what she is allergic to in mpq, or rule it out.The incident is being reported due to the lack of information regarding the severity of the reaction and the likelihood it was related to mpq.We will continue to gather more information and add it as it becomes available.
Event or Problem Description
A (b)(6) year-old female patient with a history of stress incontinence, post-menopausal bleeding and urge incontinence was implanted with macroplastique (mpq) implants on (b)(6) 2017.Forty-eight hours after the implantation, the patient experienced an allergic reaction which caused stiffness in her hands that progressed to increased pain in the joints of her hands.The patient's hands became extremely red and were hot to the touch.A doctor prescribed the patient with a 3 day course of 60 mg of prednisone.Patient stated she felt better the morning after taking the prednisone.The bulking agent is still implanted in the patient.

• Brand Name: MACROPLASTIQUE IMPLANTS
• Common Device Name: URETHERAL BULKING AGENT
• Manufacturer (Section D): UROPLASTY, LLC; 5420 feltl road; minnetonka MN 55343
• MDR Report Key: 7333677
• Report Number: 3002647932-2018-00005
• Device Sequence Number: 1163831
• Product Code: LNM
• UDI-Device Identifier: 08717591240266
• UDI-Public: 08717591240266
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: MPQ-2.5
• Device Catalogue Number: MPQ-2.5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR