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

Catalog Number F5PG015

Device Problem Off-Label Use (1494)

Patient Problem Swelling/ Edema (4577)

Event Date 10/23/2022

Event Type  Injury  

Event 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.

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
• 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, CA 92075 ; 8583864140
• MDR Report Key: 15809051
• MDR Text Key: 303799402
• Report Number: 3011277972-2022-00005
• Device Sequence Number: 1
• Product Code: ORG
• UDI-Device Identifier: 00850034511535
• UDI-Public: 00850034511535
• 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: Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: F5PG015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2022
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ANTIBIOTICS.; STEROID,
• Patient Outcome(s): Other