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

Catalog Number	F5PG016
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	11/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Trend analysis of the lot did not discover any reports of complaints with similar failure modes within the lot.The device was not made available for investigation, nor were any pictures.
Event or Problem Description
Patient adverse reaction: swelling and redness on scalp and forehead, swelling of eye area, rash and redness on legs.

• 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): TRIDENT MANUFACTURING; 41w275 railroad street; pingree grove 60140 6314
• Manufacturer Contact: trevor denbo ; 420 stevens ave; suite 220; solana beach, CA 92075
• MDR Report Key: 18342384
• Report Number: 3011277972-2023-00008
• Device Sequence Number: 18244523
• Product Code: ORG
• UDI-Device Identifier: 00850034511535
• UDI-Public: 00850034511535
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2023

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: 04/28/2025
• Device Catalogue Number: F5PG016
• Device Lot Number: BH230428
• 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: 11/17/2023
• Initial Report FDA Received Date: 12/17/2023
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown