MAUDE Adverse Event Report: MANAMED PLASMAFLOW; SLEEVE, LIMB, COMPRESSIBLE

Model Number	PF0001
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	06/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is based on a retrospective review of previously unreported complaints, specifically concerning an alleged case of deep vein thrombosis (dvt) that occurred despite the use of the product.The provided information was insufficient to determine any health impact.On (b)(6) 2024, the patient was contacted by phone, who provided the following details: the patient had surgery on (b)(6) 2023, and wore the device on the day of surgery and during the night, but was unsure if it was used the following day.The device did not display any error codes and appeared to operate normally.On (b)(6) 2023, the patient was diagnosed with dvt.Additionally, the patient expressed frustration about being charged for the device by their provider despite being told there would be no charge.It is unclear what instructions the patient received from their physician or whether those instructions were followed.The device was returned to manamed for analysis, where it operated normally in all modes and showed no error codes.One sleeve recorded 10 hours of use, and the other recorded 12 hours.
Event or Problem Description
The patient sent a written note to his provider indicating that he was diagnosed with dvt despite using the product.The message was passed on to manamed via email on 02/14/2024.

• Brand Name: PLASMAFLOW
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): MANAMED; 2612 sirius dr; denton TX 76208
• Manufacturer (Section G): MANAMED; 2612 sirius dr; denton TX 76208
• Manufacturer Contact: kevin amacker ; 2612 sirius dr; denton, TX 76208
• MDR Report Key: 19729950
• Report Number: 3011767724-2024-00002
• Device Sequence Number: 8147339
• Product Code: JOW
• UDI-Device Identifier: 00850998008003
• UDI-Public: 00850998008003
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K160318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/11/2024

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: Lay User/Patient
• Device Model Number: PF0001
• Device Lot Number: PO101112A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown