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

Model Number F5PG015

Device Problem Off-Label Use (1494)

Patient Problem Subcutaneous Nodule (4548)

Event Date 05/11/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 300702398
• Report Number: 3011277972-2022-00003
• Device Sequence Number: 1
• Product Code: ORG
• UDI-Device Identifier: 00850034511559
• UDI-Public: 00850034511559
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK170136
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: F5PG015
• Device Catalogue Number: F5PG015
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2022
• 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