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

Model Number 12.1000

Device Problems Device Operational Issue (2914); Protective Measures Problem (3015)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/05/2017

Event Type  malfunction  

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 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
• Type of Device: THERAPEUTIC POWERED TRACTION DEVICE.
• Manufacturer (Section D): HOLLYWOG, LLC; 2830 amnicola highway; chattanooga TN 37406 3605
• Manufacturer (Section G): HOLLYWOG, LLC; 2830 amnicola highway; chattanooga TN 37406
• Manufacturer Contact: michael treas ; 2830 amnicola highway; chattanooga, TN 37406-3605 ; 4233057778
• MDR Report Key: 7014825
• MDR Text Key: 92862358
• Report Number: 3008585473-2017-00032
• Device Sequence Number: 1
• Product Code: ITH
• UDI-Device Identifier: 00853096004151
• UDI-Public: (01)00853096004151(11)170817
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Disability