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

Model Number	61-088
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): FRIDABABY LLC
• MDR Report Key: 18781801
• Report Number: MW5151967
• Device Sequence Number: 16290787
• Product Code: FLL
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date (Section B): 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 61-088
• Device Lot Number: 51002805216294
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2024
• Patient Sequence Number: 1
• Patient Age: 14 DA
• Patient Sex: Female
• Patient Weight: 2 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White