MAUDE Adverse Event Report: MOTIVE HEALTH, INC. MOTIVE KNEE SYSTEM, RIGHT & LEFT, STANDARD

Model Number	OT01-1002
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	02/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2024, the customer contacted motive customer service stating that he used the motive device to treat his right knee.After the second treatment, the customer noticed some gel pulled away from the pad and stayed on his leg; each treatment thereafter the gel degraded further.The pad read 68% of usage on the app and the customer found two burn marks on his leg.It was reported by the customer that one of the burns was deep.This customer reported that he had completed 6 treatments: 10 min (1); 30 minutes (2), 30 minutes (3); 30 minutes (4); 30 minutes (5); 30 minutes (6).Initially the customer used a dime size about of electrode gel on his leg before treatment; however, the treatment discomfort prompted him to increase the amount to electrode gel that was used on his leg before treatment.Treatment time and levels: therapy time (minutes): vmo intensity @start vmo intensity @end rf intensity @start rf intensity @end 1 minutes on (b)(6)2024) , 5 40 2 40 29 minutes on (b)(6) 2024) , 52 58 39 46 30 minutes on (b)(6) 2024) , 61 67 54 58 30 minutes on (b)(6) 2024) , 60 72 52 68 30 minutes on (b)(6) 2024 , 59 67 63 72 30 minutes on (b)(6) 2024.60 55 57 54 a review of the device history record (dhr) showed this device including the stim generator, garment and electrodes had met all the applicable manufacturing specifications.The customer discarded the component / therapy pad it will not be returned.
Event or Problem Description
On (b)(6) 2024, the customer contacted motive customer service stating that he used the motive device to treat his right knee.After the second treatment, the customer noticed some gel pulled away from the pad and stayed on his leg; each treatment thereafter the gel degraded further.The pad read 68% of usage on the app and the customer found two burn marks on his leg.It was reported by the customer that one of the burns was deep.Ths customer had completed 6 treatments: 10 min (1); 30 minutes (2), 30 minutes (3); 30 minutes (4); 30 minutes (5); 30 minutes (6).Initially the customer used a dime size about of electrode gel on his leg before treatement; however, the treatment discomfort prompted him to increase the amount to electrode gel that was used on his leg before treatment.

• Brand Name: MOTIVE KNEE SYSTEM, RIGHT & LEFT, STANDARD
• Common Device Name: MOTIVE KNEE SYSTEM, RIGHT & LEFT, STANDARD
• Manufacturer (Section D): MOTIVE HEALTH, INC.; 2120 east 6th street; suite 8; tempe AZ 85288
• Manufacturer (Section G): MOTIVE HEALTH, INC.; 2120 east 6th street; suite 8; tempe AZ 85288
• Manufacturer Contact: peter kilpatrick ; 2120 east 6th street; suite 8; tempe, AZ 85288 ; 8776684838
• MDR Report Key: 18861530
• Report Number: 3011466827-2024-00001
• Device Sequence Number: 15513739
• Product Code: IPF
• UDI-Device Identifier: 00850022650345
• UDI-Public: 00850022650345
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K220738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/29/2024

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 Expiration Date: 08/14/2025
• Device Model Number: OT01-1002
• Device Catalogue Number: OT01-1002
• Device Lot Number: Y081423-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/02/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White