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

Model Number MPQ-2.5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rash (2033)

Event Date 03/11/2016

Event Type  Injury  

Manufacturer Narrative

We are continuing to reach out to the healthcare professional for additional information.The latest communication was on (b)(6) 2016 with follow-up messages left on(b)(6) 2016.Although no confirmation of a link between the rash and mpq-2.5 has been determined we are taking a conservative approach in reporting this event.If additional information becomes available a follow-up report will be submitted.

Event Description

A female patient received the mpq implant and after the procedure developed a rash over her entire body.The patient had received the mpq implant on one prior occasion with no report of a rash.The patient went to an allergy specialist that couldn't confirm or deny that the mpq implant caused an allergic reaction.The allergist thought the patient may have become sensitized to the mpq implant after the first treatment.The patient was prescribed prednisone for the rash and whenever the patient stops taking prednisone the rash reappears.

• 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: jason skramsted ; 5420 feltl road; minnetonka, MN 55343 ; 9524266161
• MDR Report Key: 5717404
• MDR Text Key: 47131802
• Report Number: 3002647932-2016-00001
• 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: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/10/2016

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
• Device Operator: Health Professional
• Device Model Number: MPQ-2.5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2016
• Initial Date FDA Received: 06/10/2016
• 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
• Patient Outcome(s): Required Intervention