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

Model Number	F5PG016
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Nodule (4551)
Date of Event	07/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Presumed aspiration and subsequent injection of separation gel under the skin which is presumed to have caused an allergic reaction.All evidence supports user error.
Additional Manufacturer Narrative
The report from the patient to the distributor indicates that this product was used off label and was administered by a nurse on herself without prior experience.Locations were "under my under eyes, 2 spots in my scalp, and 2 blebs to a scar on my neck and 1 to a deep chest wrinkle." the report from the distributor quotes the user/patient and indicates that she did not read the accompanied instructions for use but instead relied on online videos from unnamed sources.This is further supported by a quote referencing a memory of a glo nurse's advice not to let the needle touch the gel; had the user/patient read the instructions she would have seen that instruction within.She indicated within that report that she mistook the gel for prp that would not draw up into her needle.

• Brand Name: PROGEN
• 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 92075 ; 8583864140
• MDR Report Key: 15479447
• Report Number: 3011277972-2022-00001
• Device Sequence Number: 20193354
• Product Code: LKN
• UDI-Device Identifier: 00850034511559
• UDI-Public: 00850034511559
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/23/2022

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 Expiration Date: 03/04/2024
• Device Model Number: F5PG016
• Device Catalogue Number: F5PG016
• Device Lot Number: 0304224360-A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2022
• Initial Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown