MAUDE Adverse Event Report: BIMINI HEALTH TECH PROGEN PRP; AUTOMATED BLOOD CELL SEPARATOR

Catalog Number	F5PG015
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	04/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Transient swelling and redness which migrated from top of head to left front side, then to forehead, and finally to eyelids.
Additional Manufacturer Narrative
Practitioners who use this product just under the skin are intending to stimulate platelet activation by imitating the body's natural injury response, which is consistent with swelling and redness.This effect is well supported in the literature.Using prp in this manner, for hair growth in this case, is off label use.The device was not made available for investigation, nor were any pictures.

• Brand Name: PROGEN PRP
• Common Device Name: AUTOMATED BLOOD CELL SEPARATOR
• Manufacturer (Section D): BIMINI HEALTH TECH; 420 stevens ave; suite 220; solana beach CA 92075
• Manufacturer (Section G): KMI IMI GROUP; 4 autry; irvine, CA 92618
• Manufacturer Contact: trevor denbo ; 420 stevens ave; suite 220; solana beach, CA 92075 ; 8583864140
• MDR Report Key: 17132072
• Report Number: 3011277972-2023-00001
• Device Sequence Number: 6457720
• Product Code: ORG
• UDI-Device Identifier: 00850034511535
• UDI-Public: 00850034511535
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BK170136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 06/14/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: F5PG015
• Device Lot Number: 0606224401-A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEXAMETHASONE INJECTIONORAL PREDNISONE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown