MAUDE Adverse Event Report: ORTHOCOR MEDICAL ORTHOCOR MEDICAL; ACTIV8

Model Number	SPC-00209
Medical Device Problem Codes	Failure to Charge (1085); Overheating of Device (1437)
Health Effect - Clinical Code	Skin Burning Sensation (4540)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
User's first battery would not stay charged; we sent out a new battery pack and it got hot while charging.We are sending out a new device to him with an extra battery pack.Spoke to patient to make sure he received the new device, he let me know that it was hot to the touch and felt like it burned him, but he has no lingering redness or blistering and did not need to seek medical attention.

• Brand Name: ORTHOCOR MEDICAL
• Common Device Name: ACTIV8
• Manufacturer (Section D): ORTHOCOR MEDICAL; 8611 w 35w service dr ne; suite 180; blaine MN 55449
• Manufacturer (Section G): ORTHOCOR MEDICAL; 8611 w 35w service dr ne; suite 180; blaine MN 55449
• Manufacturer Contact: kevin caye ; 8611 w 35w service dr ne; suite 180; blaine, MN 55449 ; 6514409345
• MDR Report Key: 22979727
• Report Number: 3008216220-2025-00001
• Device Sequence Number: 9519073
• Product Code: ILX
• UDI-Device Identifier: 00851979007305
• UDI-Public: 00851979007305
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K241395
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: SPC-00209
• Device Catalogue Number: 620204
• Device Lot Number: VBM050925-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male