MAUDE Adverse Event Report: HOLLYWOG, LLC MODPOD; THERAPEUTIC POWERED TRACTION DEVICE.

Model Number	12.1000
Medical Device Problem Codes	Device Operational Issue (2914); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The dhr review shows the device performed as intended when it was manufactured.The device was evaluated.Unable to replicate customer's complaint, operated to spec.Power pcb was re-aligned so the ports and switch were more easily accessible.
Event or Problem Description
The device has full screen functionality, but will not pull at all.He and his ca has tried turning off and on the device.When asked to calibrate his device, it will not bring him to the screen to calibrate.Also, the patient switch would not end treatment previously, so the ca is sending back the patient switch.

• Brand Name: MODPOD
• Common Device Name: THERAPEUTIC POWERED TRACTION DEVICE.
• Manufacturer (Section D): HOLLYWOG, LLC; 2830 amnicola highway; chattanooga TN 37406 3605
• MDR Report Key: 7014825
• Report Number: 3008585473-2017-00032
• Device Sequence Number: 1331946
• Product Code: ITH
• UDI-Device Identifier: 00853096004151
• UDI-Public: (01)00853096004151(11)170817
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K150695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/09/2017

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: No Information
• Device Model Number: 12.1000
• Device Catalogue Number: 12.1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Was the Report Sent to FDA?: No
• Device Age: 2 MO
• Event Location: Outpatient Treatment Facility
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2017
• Initial Report FDA Received Date: 11/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability