MAUDE Adverse Event Report: DEGANIA SILICONE LTD MON A THERM FOLEY CATHETER WITH TEMPERATURE SENSOR

Model Number	102201101480TY
Medical Device Problem Code	Decreased Sensitivity (2534)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Following the insertion of the mon a therm foley catheter with temperature sensor it had a reading of 34.8, but upon using a rectal probe thermometer the reading was 36.4, there was no patient injury.

• Brand Name: MON A THERM FOLEY CATHETER WITH TEMPERATURE SENSOR
• Common Device Name: FOLEY CATHETER WITH TEMPERATURE SENSOR
• Manufacturer (Section D): DEGANIA SILICONE LTD; degania bet; degania bet, 15130 00; IS 1513000
• Manufacturer (Section G): DEGANIA MEDICAL DEVICES; imt manesar, gurgaon - 122050; haryana, india; gurgaon, haryana 12205 0; IN 122050
• Manufacturer Contact: jawan asla ; degania bet; degania bet, 15130-00 ; IS 1513000
• MDR Report Key: 19219420
• Report Number: 8030107-2024-00001
• Device Sequence Number: 8241617
• Product Code: EZL
• UDI-Device Identifier: 30884522000066
• UDI-Public: (01)30884522000066
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K063442
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2024

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 Expiration Date: 03/17/2026
• Device Model Number: 102201101480TY
• Device Catalogue Number: 102201101480TY
• Device Lot Number: S21000713
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2021
• 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: Disability; Other
• Patient Sex: Unknown