NEXTEMP LATEX-FREE SINGLE-USE CLINICAL THERMOMETER REORDER CODE 1112

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-06 for NEXTEMP LATEX-FREE SINGLE-USE CLINICAL THERMOMETER REORDER CODE 1112 manufactured by Medtronic Indicators, Inc..

Event Text Entries

[174389573] We tried using the nextemp single use thermometers on 3 individuals to see if they were feverish. I also put one device into hot water to see if it was working. None of the devices provided temperature indication. The photo shows an unused device and a used device just used on myself. I am not feverish and these devices cannot be distinguished. Note that entire box of 100 devices has been stored in a refrigerator (below the stated 30c) since purchase. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5092047
• MDR Report Key: 9558409
• Date Received: 2020-01-06
• Date of Report: 2020-01-02
• Date of Event: 2020-01-02
• Date Added to Maude: 2020-01-07
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: NEXTEMP LATEX-FREE SINGLE-USE CLINICAL THERMOMETER
• Generic Name: THERMOMETER CLINICAL COLOR CHANGE
• Product Code: FQZ
• Date Received: 2020-01-06
• Model Number: REORDER CODE 1112
• Lot Number: 07555
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDTRONIC INDICATORS, INC.

Device Sequence Number: 2

• Brand Name: NEXTEMP LATEX-FREE SINGLE-USE CLINICAL THERMOMETER
• Generic Name: THERMOMETER CLINICAL COLOR CHANGE
• Product Code: FQZ
• Date Received: 2020-01-06
• Model Number: REORDER CODE 1112
• Lot Number: 07555
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: MEDTRONIC INDICATORS, INC.

Device Sequence Number: 3

• Brand Name: NEXTEMP LATEX-FREE SINGLE-USE CLINICAL THERMOMETER
• Generic Name: THERMOMETER CLINICAL COLOR CHANGE
• Product Code: FQZ
• Date Received: 2020-01-06
• Model Number: REORDER CODE 1112
• Lot Number: 07555
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: MEDTRONIC INDICATORS, INC.

Device Sequence Number: 4

• Brand Name: NEXTEMP LATEX-FREE SINGLE-USE CLINICAL THERMOMETER
• Generic Name: THERMOMETER CLINICAL COLOR CHANGE
• Product Code: FQZ
• Date Received: 2020-01-06
• Model Number: REORDER CODE 1112
• Lot Number: 07555
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: MEDTRONIC INDICATORS, INC.

Device Sequence Number: 5

• Brand Name: NEXTEMP LATEX-FREE SINGLE-USE CLINICAL THERMOMETER
• Generic Name: THERMOMETER CLINICAL COLOR CHANGE
• Product Code: FQZ
• Date Received: 2020-01-06
• Model Number: REORDER CODE 1112
• Lot Number: 07555
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: MEDTRONIC INDICATORS, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-01-06