MAUDE Adverse Event Report: BRAUN / KAZ USA, INC., A HELEN OF TROY COMPANY NO TOUCH AND FORHEAD THERMOMETER; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 328785730005

Device Problems Product Quality Problem (1506); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Fever (1858); Malaise (2359)

Event Date 12/16/2022

Event Type  malfunction  

Event Description

The braun no touch and forehead thermometer is extremely inaccurate and could lead to harm.Some of the product specifications are as follows: tcin: (b)(4) ; upc: (b)(4); item number (dpci): 094-06-0009.I purchased this at target for (b)(6) and was immediately disappointed with the poor results.It seemed to produce a believable reading perhaps 1 out of 10 attempts.I made sure to practice thoroughly at the placement, but it did not help.5 different results from 5 successive readings with variations of 1-3 degrees f.Only randomly did the results agree with the oral and tympanic thermometers i have.However, i reached for it last night to check on my 7 year old, who was tossing, turning, and moaning in her sleep with the flu.I thought it would be the least invasive method and help me keep her asleep.When it showed me 107.9 degrees f, i quickly followed up by feeling her forehead.She was warm but not fiery.Tried the tympanic device next which showed 101.9.That seemed more believable.She was awake then, so i took and oral reading as well and got 101.8.A little children's tylenol was served and we all slept peacefully through the night.Another parent might have reacted very differently.A frantic 911 call or a risky late night race to the er.After this experience my plan was simply to leave a review on the target website.But when i saw how many other reviewers had experiences almost identical to mine i thought to take it one step farther.I believe a product like this should not be allowed to be sold.It is one of the most, if not the most, expensive thermometers in the store and it does not work well.Parents make highly consequential decisions based on the information these devices provide, and it is not hard to imagine how some outcomes could be quite negative.

• Brand Name: NO TOUCH AND FORHEAD THERMOMETER
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): BRAUN / KAZ USA, INC., A HELEN OF TROY COMPANY
• MDR Report Key: 16026698
• MDR Text Key: 306076822
• Report Number: MW5113915
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• 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: 12/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328785730005
• Device Catalogue Number: 094-06-0009
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White