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	10/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Swelling under the eyes 11 days after having platelet rich plasma obtained from the device injected in that area.No conclusive association has been established.
Additional Manufacturer Narrative
Practitioners who use this product with the skin are intending to stimulate platelet activation imitating the body's natural injury response, which is consistent with swelling.This effect is well supported in the literature.The patient may also be experiencing an allergic reaction due to the use of the skinpen used during the same procedure, which is contraindicated for patients with an allergy to nickel as this patient has.This allergic reaction may have been further triggered by the intake of mango which the practitioner stated was an unusual intake for the patient.The patient is also allergic to kiwi, so a mango allergy is not unlikely.

• 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: 15809051
• Report Number: 3011277972-2022-00005
• Device Sequence Number: 7043418
• Product Code: ORG
• UDI-Device Identifier: 00850034511535
• UDI-Public: 00850034511535
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2022

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 Catalogue Number: F5PG015
• 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: 11/14/2022
• Initial Report FDA Received Date: 11/16/2022
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANTIBIOTICS.; STEROID,
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown