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

Model Number F5PG016

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

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

Event Date 07/31/2022

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 300576139
• Report Number: 3011277972-2022-00001
• Device Sequence Number: 1
• Product Code: LKN
• 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: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/29/2022
• Initial Date FDA Received: 09/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• 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