MAUDE Adverse Event Report: PRECISION MEDICAL PRODUCTS, INC DEFENDER; DEEP VEIN THROMBOSIS PREVENTION SLEEVE

Model Number	08-0028
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	02/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was wearing device on calf of left leg.Staff noted patient had a degree of lack of sensitivity on left leg and patient is positive for mrsa.Va nursing staff was reviewing the patient's skin and identified skin injury, then they contacted wound nurse, who consulted for wound order.The wound rn couldn't for sure determine if it was a wound, burn or med device related injury, but where the "wound" was is right under where the battery pack was resting.Staff took off defenders and left them off.And have discontinued use for the whole floor for the time being.Patient was forwarded to the wound team and developed a plan of care.Recovery and status update of the patient's skin condition is still unknown.

• Brand Name: DEFENDER
• Common Device Name: DEEP VEIN THROMBOSIS PREVENTION SLEEVE
• Manufacturer (Section D): PRECISION MEDICAL PRODUCTS, INC; 2217 plaza drive; rocklin CA 95765
• Manufacturer (Section G): CLEARLAKE-TECH, INC; 205 hwy 22 e; clear lake SD
• Manufacturer Contact: taylor nordeen ; 2217 plaza drive; rocklin, CA 95765 ; 9162894002
• MDR Report Key: 24518509
• Report Number: 3016000973-2026-00001
• Device Sequence Number: 18573067
• Product Code: JOW
• UDI-Device Identifier: 00194832000052
• UDI-Public: 00194832000052
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K212731
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/12/2026

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 Model Number: 08-0028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/05/2026
• 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: Required Intervention; Other
• Patient Sex: Unknown