MAUDE Adverse Event Report: BIMINI HEALTH TECH PROGEN PRP 15ML; AUTOMATED BLOOD CELL SEPARATOR

Model Number	F5PG015
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Subcutaneous Nodule (4548)
Date of Event	05/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product was used off label to obtain prp for scalp injections for hair growth.Some practitioners are accustomed to devices that have very low platelet counts.By delivering a much higher concentration and larger volume of total platelets, the patients are experiencing more of an effect than they did when using a lower quality product.Practitioners who use this product with the skin are intending to stimulate platelet activation imitating the body's natural injury response, which is consistent pain and swelling.This is well supported in the literature.These nodules may just be localized swelling.
Event or Problem Description
Nodule development under the skin where prp obtained from the use of the device was used to support hair growth.

• Brand Name: PROGEN PRP 15ML
• Common Device Name: AUTOMATED BLOOD CELL SEPARATOR
• Manufacturer (Section D): BIMINI HEALTH TECH; 420 stevens ave; suite 220; solana beach 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: 15495526
• Report Number: 3011277972-2022-00003
• Device Sequence Number: 17386401
• Product Code: ORG
• UDI-Device Identifier: 00850034511559
• UDI-Public: 00850034511559
• 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: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/26/2022

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 Model Number: F5PG015
• Device Catalogue Number: F5PG015
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown