MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. LEVEL 1 TEMPERATURE SENSOR SKIN PROBE; THERMOMETER, ELECTRONIC, CLINICAL

Catalog Number	STS-400
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Localized Skin Lesion (4542)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2 - dob: year has been provided; month and day is unknown.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the probe tended to tear at the end, leaving the wire exposed, which could lead to skin injuries in premature infants.In the case described, an injury occurred on the sole of the foot.The site was reportedly changed once per day.During one such change, the head of the probe had torn off.This had gone unnoticed, and the wire had then been adhered to the sole of the foot.According to the report, this led to a small open skin lesion (approx.1×2 cm).It was stated that the premature infant was being treated in the pediatric intensive care unit.They reported that the skin lesion had been treated with bepanthen cream.The skin had healed quickly, and the premature infant was said to be doing well.
Additional Manufacturer Narrative
One unused sample was received for evaluation for the complaint that the probe tended to tear at the end, leaving the wire exposed, which could lead to skin injuries in premature infants.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.As received, one temp sensor was returned with a partial adhesive pad and slightly exposed thermistor wiring.Four temp sensors were returned with exposed thermistor wiring, with the foam pad disk missing from the assembly.No other damages or anomalies were observed.In order to replicate clinical use, the new temperature sensor was adhered to simulated skin.The complaint of breakage/cut can be confirmed.The probable cause due to an unintentional pulling force on the wiring.The cause of the lesion cannot be determined.

• Brand Name: LEVEL 1 TEMPERATURE SENSOR SKIN PROBE
• Common Device Name: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23896297
• Report Number: 3012307300-2025-13766
• Device Sequence Number: 5344643
• Product Code: FLL
• UDI-Device Identifier: 30695085000116
• UDI-Public: (01)30695085000116(17)280429(10)6114858
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K864195
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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: Health Professional
• Device Catalogue Number: STS-400
• Device Lot Number: 6114858
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BEPANTHEN CREAM
• Patient Age: 11 MO
• Patient Sex: Male