MAUDE Adverse Event Report: PROLLENIUM MEDICAL TECHNOLOGIES INC REVANESSE VERSA+ WITH LIDOCAINE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Swelling (2091); Reaction (2414)

Event Type  malfunction  

Event Description

The patient was injected with revanesse versa+ (19b045) by (b)(6) (rn) on (b)(6) 2019 into the lips.Total 1.0 ml of the product was injected, 0.8 ml to r and l mannequin lines and 0.2 ml to r and l upper lip vermillion border area.The patient began experiencing swelling on her face and lips approximately 5 days after revanesse versa+ injections.The symptoms continued with irregular, red itchy rash/welts on her torso and neck particularly in the early morning hours.Patient went to local emergency for a blood panel where nothing unusual was found and they prescribed the prednisone 20 mg and loratadine 10 mg medicines for her symptoms.On (b)(6) 2019 patient called nurse injector and informed her that she had to take the medicines daily to relive her symptoms.If she missed a day the breakout would return.Patient asked if nurse injector could reverse the product.Before starting for any other treatment, patient wanted to see an allergist so she went to the allergist on (b)(6) 2019, where nothing unusual was found.Patient came to see the nurse injector on (b)(6) 2019 and the nurse injector injected the same treatment sites with hyaluronidase, 1.5 ml to each side of her mannequin lines and 0.5 ml to each side of upper lip.After the hyaluronidase treatment, there were no breakouts and she did not take any medicines.On (b)(6) 2019 the patient replaced the dissolved filler with juvederm product.

• Brand Name: REVANESSE VERSA+ WITH LIDOCAINE
• Type of Device: REVANESSE VERSA+ WITH LIDOCAINE
• Manufacturer (Section D): PROLLENIUM MEDICAL TECHNOLOGIES INC; 138, industrial parkway north; aurora, L4G 4 C3; CA L4G 4C3
• Manufacturer (Section G): PROLLENIUM MEDICAL TECHNOLOGIE INC; 9121 anson way, suite 213; raleigh NC 27615
• Manufacturer Contact: colin hall ; 138, industrial parkway north; aurora L4G 4-C3 ; CA L4G 4C3
• MDR Report Key: 8802608
• MDR Text Key: 216219114
• Report Number: 3004423487-2019-00007
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160042/S003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR