MAUDE Adverse Event Report: BESTMED LLC INFARED EAR THERMOMETER UP AND UP; NONE

Model Number KI-8160

Device Problems Break (1069); Difficult to Remove (1528); Material Separation (1562)

Patient Problem No Code Available (3191)

Event Type  Other  

Event Description

This morning, i was taking my temperature using the up and up brand ear thermometer and the yellow covering that protects the sensor broke free and lodged in my ear.Inspected the thermometer prior to use and did not notice any breaks or tears.I went to the urgent care clinic in my neighborhood where they extracted the plastic piece.There was no further damage to my ear.Purchase date: (b)(6) 2013 this date is an estimate.I still have the product in my possession: yes.The product was damaged before the incident: no.The product was modified before the incident: no.Have you contacted the manufacturer: yes.Explanation: i submitted an online notice to (b)(6) through their website.(b)(4).

• Brand Name: INFARED EAR THERMOMETER UP AND UP
• Type of Device: NONE
• Manufacturer (Section D): BESTMED LLC
• MDR Report Key: 4280310
• MDR Text Key: 5227024
• Report Number: MW5039261
• 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: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: KI-8160
• Device Lot Number: 1212
• Patient Sequence Number: 1
• Patient Age: 40 YR