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 Type  Injury  

Event Description

Swelling and pressure at injection sight (under the eye).

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 and pressure.This effect is well supported in the literature.This however is off label use.The patient may also be experiencing reactions from the use of other products used at the same time (e.G."intense eye cream") used during the same procedure.The device was not made available for investigation, nor were any pictures.

• 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: 15875104
• MDR Text Key: 304419583
• Report Number: 3011277972-2022-00006
• Device Sequence Number: 1
• Product Code: ORG
• 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: Nurse
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: F5PG015
• Device Lot Number: 1105214308-A
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2021
• 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
• Treatment: "INTENSE EYE CREAM"; "SKIN NECTAR AND FIRMING SERUM"; ANTIBIOTIC 3 TIMES; DOXYCYCLINE; MICRONEEDLING; PREDNISONE 2 TIMES; ZYRTEC, DAILY
• Patient Outcome(s): Other