MAUDE Adverse Event Report: CROWN AESTHETICS / BIMINI HEALTH TECH CROWN AESTHETICS PROGEN PRP COLLECTION TUBE; PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING

Model Number PROGEN-A30

Device Problem Defective Component (2292)

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Nodule (4551)

Event Date 07/31/2022

Event Type  malfunction  

Event Description

Defect in the lab tube used for prp collection and separation.The is a gel layer that separates the plasma from rbc.The plasma is aspirated from the tube and used for reinjection in aesthetics to rejuvenate the skin.When i aspirated the prp there was a chunk of the gel separator that displace and was, unknowingly at the time (because it was all yellow and appeared to be plasma, but after it had set awhile and the plasma is now clear, you can clearly see the chunk of white gel) with my prp.Having this in the plasma and in contact with my needle when aspirating had caused a severe allergic reaction at injection sites.After treatment with oral and injected steroids the inflammation has resolved but there are persistent visible and palpable nodules under my skin at injection sites from this gel that was in my unknowingly in my prp.Fda safety report id# (b)(4).

• Brand Name: CROWN AESTHETICS PROGEN PRP COLLECTION TUBE
• Type of Device: PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING
• Manufacturer (Section D): CROWN AESTHETICS / BIMINI HEALTH TECH
• MDR Report Key: 15380048
• MDR Text Key: 299593378
• Report Number: MW5111914
• Device Sequence Number: 1
• Product Code: ORG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PROGEN-A30
• Device Lot Number: 0304224360-A
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other