MAUDE Adverse Event Report: INNOVATIVE MEDICAL EQUIPMENT, LLC THERMAZONE THERMAL THERAPY DEVICE; PACK, HOT OR COLD, WATER CIRCULATING

Model Number 003-99

Device Problem Use of Device Problem (1670)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 10/17/2017

Event Type  Injury  

Manufacturer Narrative

In an email dated (b)(6), patient stated "i know that the machine may be ok and it could very well be my mistake." page 5 of the thermazone safety and instruction manual includes detailed instructions regarding how to use the preset timer modes.Specifically, "you must set the timer before you select the temperature mode if you want to use any of the preset timers." pages 6 - 7 of the thermazone safety and instruction manual include detailed instructions regarding choice of desired temperature mode and comfort level.Warnings are included regarding duration of application at certain temperature levels, including those used by the patient.Page 8 specifically states "for safety reasons, the pad is not meant to be worn while sleeping." a label on the control unit specifically states "never use while sleeping." despite the incident, patient requested a replacement control unit for use in cool mode post back-surgery, which was delivered to her.Based on the information provided by the patient and the fact that testing of the suspect medical device revealed no malfunction, it appears the patient did not operate the device according to the manufacturer's instructions for use.

Event Description

Patient was prescribed the product for chronic back pain after injury and surgery, but the incident occurred when patient decided to try the product on her shoulder.Patient received control unit and multiple pads.Patient received oral instructions from her occupational therapist on how to use the device, and was told it was safe to sleep in because of the auto shut off program.Patient said instructions for use accompanied the product - "booklet and each pad has paper in it with instructions" - and that she reviewed both documents.Patient used the product for the first time, expecting it to shut off automatically.Patient does not recall the sequence of buttons she pressed on the control unit prior to application of the large shoulder pad.When asked what preset timer mode she used, patient could not recall and responded "i cannot recall but assuming this is where i thought the machine was in the correct mode." patient believes the heat level was set to "8 or 9".Patient fell asleep for approximately 1.5 hours.Upon waking up, patient realized the product has not turned off as she had expected, and her arm felt hot and sore.Patient took off the shoulder pad, "revealing burns." patient sought medical attention on (b)(6) 2017 and was prescribed an ointment.Patient sought follow-up treatment on (b)(6) 2017.Patient said, "the burn has greatly improved, but probably will be left with a scar on the top of my shoulder." the suspect medical device was shipped from patient to manufacturer for inspection, and was received nov.6, 2017.The suspect medical device was tested to determine whether it has malfunctioned.Temperature levels were with specifications.All preset timer modes operated according to specifications.Nothing from the inspection indicates the suspect medical device malfunctioned.

• Brand Name: THERMAZONE THERMAL THERAPY DEVICE
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): INNOVATIVE MEDICAL EQUIPMENT, LLC; 29001 cedar road; suite 325; lyndhurst OH 44124
• Manufacturer Contact: glen guyuron ; 29001 cedar road; suite 325; lyndhurst, OH 44124 ; 4406461286
• MDR Report Key: 7035117
• MDR Text Key: 92160450
• Report Number: 3007353136-2017-00001
• Device Sequence Number: 1
• Product Code: ILO
• UDI-Device Identifier: 00854682001356
• UDI-Public: 00854682001356
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2020
• Device Model Number: 003-99
• Device Catalogue Number: 003-99
• Device Lot Number: 17252917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR