MAUDE Adverse Event Report: FRIDABABY LLC QUICK READ RECTAL THERMOMETER; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 61-088

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2024

Event Type  malfunction  

Event Description

Frida quick temp thermometer model 61-088: used on two week old premature newborn as she had nasal congestion at home and it consistently resulted in lower than normal range temps.Was advised by nurse line of baby's pediatrician to go to peds urgent care.There the baby had a normal temperature with their thermometer and i immediately checked with the frida device i brought with me after (as in right after the doctor pulled out their rectal thermometer i put it in) and the frida device showed over one degree lower than the office device, again putting the baby's temperature out of range (lower), likely falsely.I searched for any concerns of inaccurate readings from frida devices and saw a complaint made from a 2021 bought device on here; i'm worried the inaccuracies are real and there lies further risks to new parents of undue anxiety and money/time loss from potential totally unnecessary care visits.

• Brand Name: QUICK READ RECTAL THERMOMETER
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): FRIDABABY LLC
• MDR Report Key: 18781801
• MDR Text Key: 336322301
• Report Number: MW5151967
• 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: Unknown
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 61-088
• Device Lot Number: 51002805216294
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 14 DA
• Patient Sex: Female
• Patient Weight: 2 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White