MAUDE Adverse Event Report: SAFETY 1ST THERMOMETER; SAFETY 1ST ADVANCED SOLUTIONS EASY READ 4-IN-1 THERMOMETER

Model Number TH053

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2016

Event Type  Injury  

Event Description

I am livid about the quality of a safety 1st thermometer i've been using to take my infants temperature (rectally).The model number is th053.It's been acting "quirky" for a couple of weeks now; the mode will switch from rectal to oral with no prompting from me.I get three error messages in a row when taking my baby's temperature before i get a reading.Last night, i took my baby's temperature before his bedtime because he's had an ongoing virus with an elevated temperature.The reading was 100.5; a true fever that required medication.Because my baby did not feel that warm to me, i took his temperature a second time; it read 100.3.Because of the unreliable issues i had been having with the safety 1st thermometer, i had recently purchased a new thermometer of a different brand.When i used the new thermometer, the reading was 99.0; a reading consistent with how warm my baby felt to me.I am appalled at the problems with the thermometer - had i trusted it's reading, i would have medicated my child unnecessarily.I will never buy a safety 1st product again.I hope there is something you can do to rectify this issue for other parents who may be experiencing the same issue.Thank you for your attention to this matter.The retailer is (b)(6).The state is (b)(6).Purchase date: (b)(6) 2015; this date is an estimate.The product was not damaged before the incident.(b)(4).

• Brand Name: SAFETY 1ST THERMOMETER
• Type of Device: SAFETY 1ST ADVANCED SOLUTIONS EASY READ 4-IN-1 THERMOMETER
• MDR Report Key: 5463008
• MDR Text Key: 39351781
• Report Number: MW5060533
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: TH053
• Device Lot Number: 1505KJ
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4 MO