MAUDE Adverse Event Report: MEDISIM LTD. TEMPLE TOUCH PRO MCU UNIT, NON-INVASIVE CORE TEMP MONT; CONTINUOUS MEASUREMENT THERMOMETER

Model Number	81-1020TTP
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Burn(s) (1757); Rash (2033); Skin Inflammation/ Irritation (4545)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, the teams placed the ttp in preop on the patient's forehead and what i can tell from the charting, the crna did use the ttp (thermoregulation band option selected *temporal) to capture intraop temps as well.In pacu, the ttp had become dislodged and was not giving correct temperatures, so the pacu nurse removed the ttp sensor to reposition it to re-place it on the patient's forehead area and noticed that there were 4 small dark squares on the patients skin that aligned with the sensors on the ttp." deroyal industries, inc.Requested return of the device, but it has not yet been received.A supplier corrective action request (scar) will be issued to the supplier, medisim, ltd.This investigation is not complete at this time.No further information is available at this time.We will provide follow up report when additional information becomes available.
Event or Problem Description
A user facility reported, "the teams placed the ttp in preop on the patient's forehead and what i can tell from the charting, the crna did use the ttp (thermoregulation band option selected *temporal) to capture intraop temps as well.In pacu, the ttp had become dislodged and was not giving correct temperatures, so the pacu nurse removed the ttp sensor to reposition it to re-place it on the patient's forehead area and noticed that there were 4 small dark squares on the patient's skin that aligned with the sensors on the ttp.".
Additional Manufacturer Narrative
A user facility reported, the teams placed the ttp in preop on the patients forehead and what i can tell from the charting, the crna did use the ttp (thermoregulation band option selected *temporal) to capture intraop temps as well.In pacu, the ttp had become dislodged and was not giving correct temperatures, so the pacu nurse removed the ttp sensor to reposition it to re-place it on the patients forehead area and noticed that there were 4 small dark squares on the patients skin that aligned with the sensors on the ttp." deroyal industries, inc.Requested return of the device, and received it on 8/26/2025 to send to the supplier, medisim as deroyal does not have the equipment to test the device.Similarly, no inventory was checked as deroyal doesn't have the proper equipment to test.A complaint to sales ratio was conducted from 12/2023 to 9/2025 and found to be 2.065%.A supplier corrective action request (scar) will be issued to the supplier, medisim, ltd.Medisim was sent the sample on 8/26/2025.After inspection and testing it was determined that the sensor unit was missing the bio-adhesive layer.Root cause: the bio-adhesive layer was missing from the sensor unit in use.Corrective and preventive actions: medisim added a 100% in process inspection to ensure bio-adhesive used.They are also working on a design where the sensors facing upwards away from skin as well as extra protection in the usb power adaptor cable.These changes are currently in engineering, due for production q1/26.Deroyal will continue to monitor for trends around this item and issue.This investigation is complete at this time.No further information is available at this time.We will provide follow up report if additional information becomes available.

• Brand Name: TEMPLE TOUCH PRO MCU UNIT, NON-INVASIVE CORE TEMP MONT
• Common Device Name: CONTINUOUS MEASUREMENT THERMOMETER
• Manufacturer (Section D): MEDISIM LTD.; 11 hamelacha street; har tuv a industrial park; beit shemesh, 99801 01; IS 9980101
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 22852952
• Report Number: 1043214-2025-00003
• Device Sequence Number: 8403495
• Product Code: FLL
• UDI-Device Identifier: 00749756389198
• UDI-Public: 00749756389198
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K150160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 81-1020TTP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Unknown