MAUDE Adverse Event Report: WALGREENS FLEX TIP 2 SECOND DIGITAL THERMOMETER

Model Number ORG0514-F

Device Problems Defective Device (2588); Calibration Problem (2890)

Patient Problem Seizures (2063)

Event Date 06/01/2016

Event Type  Injury  

Event Description

A child had a seizure and was hospitalized because of defective thermometer that was way off.The thermometer was off by several degrees.It is made by walgreens.It is a flex tip 2 second digital thermometer with 2 second reading, (b)(6).

• Brand Name: FLEX TIP 2 SECOND DIGITAL THERMOMETER
• Type of Device: FLEX TIP 2 SECOND DIGITAL THERMOMETER
• Manufacturer (Section D): WALGREENS
• MDR Report Key: 6033590
• MDR Text Key: 57734524
• Report Number: MW5065442
• Device Sequence Number: 1
• Product Code: FLL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ORG0514-F
• Device Catalogue Number: ITEM 354062
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: NA. ; RX MEDS: NA.
• Patient Outcome(s): Hospitalization
• Patient Age: 3 YR
• Patient Weight: 11