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

Model Number MPQ-2.5

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Muscular Rigidity (1968); Pain (1994); Reaction (2414)

Event Date 09/20/2017

Event Type  Injury  

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 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
• Type of Device: URETHERAL BULKING AGENT
• 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: 7333677
• MDR Text Key: 102204336
• Report Number: 3002647932-2018-00005
• Device Sequence Number: 1
• Product Code: LNM
• UDI-Device Identifier: 08717591240266
• UDI-Public: 08717591240266
• 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,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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 the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR