MAUDE Adverse Event Report: ECTODERMA DBA COSMOFRANCE EZPRF COLLECTION SYSTEM; CENTRIFUGE ACCESSORIES

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Inflammation (1932); Blurred Vision (2137)

Event Date 05/27/2020

Event Type  Injury  

Event Description

Practitioner treated two patients with prf under eyes.No filler used.They both c/o blurry vision 2 days after treatment.On (b)(6) 2020 medical director informed this is not a common reaction to prf and recommended that both patients needed an ophthalmology evaluation on (b)(6) 2020 practitioner confirmed patients were doing fine.The blurry vision went away with swelling.Also it was discovered that one of the patients had changes of vision prior to treatment and was seen by an ophthalmologist a week prior physician spoke to a friend ophthalmologist who confirmed that swelling can potentially increase ocular pressure and cause temporary blurry vision but vascular occlusion is very unlikely in this case.

• Brand Name: EZPRF COLLECTION SYSTEM
• Type of Device: CENTRIFUGE ACCESSORIES
• 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: 16358514
• MDR Text Key: 309367094
• Report Number: 3007895168-2022-00003
• 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: 07/19/2022

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: 05/27/2020
• 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): Other