MAUDE Adverse Event Report: MOTIVE HEALTH, INC. MOTIVE THERAPY PAD, RIGHT

Model Number	OT01-1003
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, the customer stated after a few uses on therapy pad, the tacky part on the pad came off, tried to replace back on pad on next use but it did not stay; started at level 25, but did not feel any muscle movement, so increased to 50 and noticed burn mark on leg.
Additional Manufacturer Narrative
On february 12, 2024, customer stated after a few uses on therapy pad, the tacky part on the pad came off, tried to replace back on pad on next use but it did not stay; started at level 25, but did not feel any muscle movement, so increased to 50 and noticed burn mark on his leg.Treatment time and levels: therapy time (minutes): vmo intensity: rf intensity 30 minutes (b)(6) 2024).22, 22, 30 minutes (b)(6) 2024).35, 45, 30 minutes (b)(6) 2024).50, 55, 30 minutes (b)(6) 2024).55 and 50.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 complaint therapy pad was returned to the manufacturer on 03/01/2024.Evaluation analysis: removing liner showed damaged com and rf electrode gel pads.The gel pads showed edge damage (rolling/deformation) on the left edge.The hydrogel is sticky and prone to clumping/rolling when sticky faces come into contact, resulting in the "clump" formations likely due to user trying to reattach the gel to the silver traces.Closer examination showed exposed silver traces due to hydrogel deformation.Conclusion: common and rf electrodes showed hydrogel migration on the left edge resulting in exposed silver trace material.Exposed silver trace material may come in contact with user's skin resulting in burn if stimulation level was set at a high enough level.

• Brand Name: MOTIVE THERAPY PAD, RIGHT
• Common Device Name: MOTIVE THERAPY PAD, RIGHT
• 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: 18887829
• Report Number: 3011466827-2024-00002
• Device Sequence Number: 7605049
• Product Code: GXY
• UDI-Device Identifier: 00850022650369
• UDI-Public: 00850022650369
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K230533
• 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): 02/21/2024

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: 06/22/2025
• Device Model Number: OT01-1003
• Device Catalogue Number: OT01-1003
• Device Lot Number: W2023-0181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2023
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White