MAUDE Adverse Event Report: ECTODERMA DBA COSMOFRANCE EZPRF

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932)

Event Date 02/25/2020

Event Type  Injury  

Event Description

Treated on (b)(6) 2020 at 12:30 pm patient 50 years old.Occasional smoker.No swelling post procedure.Patient c/o mild burning from using hydrogen peroxide/water blend to remove blood product from face post microneedle alastin moisturizer applied at 3pm patient called c/o swelling progressively getting worse with no pain.Advised 400mg advil and ic medical director explained this could be a robust but normal reaction to prf that was injected around the mouth in a smoker.On (b)(6) 2020 sales rep spoke with the provider who went to the er with the patient, and it was confirmed that the patient had a reaction to medication that she was taking (lisinopril)".Dx: angioedema of lips/ around mouth d/t lisinopril.No tongue involvement, no respiratory distress.All vitals within normal limits.Patient sent home with steroid dose pack, epi pen, and instructions to stop lisinopril.

• Brand Name: EZPRF
• Type of Device: EZPRF
• Manufacturer (Section D): ECTODERMA DBA COSMOFRANCE; 2121 sw 3rd ave; suite 500; miami FL 33129
• Manufacturer Contact: 2121 sw 3rd ave; suite 500; miami, FL 33129 ; 3055380110
• MDR Report Key: 16357973
• MDR Text Key: 309364896
• Report Number: 3007895168-2022-00001
• Device Sequence Number: 1
• Product Code: KST
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Race: White