MAUDE Database nonsense

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
This is an entry for a product similar to ours I find laughable and impossible. I found this as part of our annual risk review meeting but this seems borderline libel. No hospital would do this without a hospital reading verifying the temperature.
MW5112710
2022/10/12 4:00:00​
InjuryFRIDABABY LLC.
2022/10/18 4:00:00​
FLL
Event Description: WE CHECKED OUR NEWBORNS TEMPERATURE USING THE FRIDABABY 3 IN 1 THERMOMETER RECEIVING A READING OF 100.5F ON A RECTAL TEMPERATURE. WE WERE ADVISED TO GO THE EMERGENCY DEPARTMENT AND OUR NEWBORN WAS HOSPITALIZED AND UNDERWENT INVASIVE PROCEDURES (LUMBAR PUNCTURE) BASED ON THIS TEMPERATURE READING. SHE NEVER REGISTERED A FEVER IN THE HOSPITAL. I WENT HOME AND RETRIEVED THE FRIDABABY THERMOMETER AND TOOK SEVERAL RECTAL TEMPERATURES IN ORDER TO CORRELATE THE THERMOMETER WITH HOSPITAL THERMOMETER READINGS. THE FRIDABABY THERMOMETER CONTINUED TO RESULT A RECTAL TEMPERATURE OF 100.5 F THROUGHOUT THE ADMISSION DESPITE OUR NEWBORN NEVER REGISTERING A TEMPERATURE ON ANY OTHER THERMOMETER USED THROUGHOUT THE HOSPITALIZATION. ALL OF HER CULTURES AND LAB WORK WERE COMPLETELY NORMAL. IT APPEARS THE FRIDABABY THERMOMETER IS GIVING AN INACCURATE AND FALSELY HIGH READING WHICH LEAD TO AN UNNECESSARY HOSPITALIZATION IN OUR CASE. FDA SAFETY REPORT ID# (B)(4).
 
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Tidge

Trusted Information Resource
Without commenting specifically on this device: I had personal experience where a sick child was initially given a diagnosis of "it's probably nothing, but if X happens be sure to go right to the ER" and when X happened about 36 hours later the ER staff tried to initiate some rather radical actions without doing anything like a set of straightforward verification checks. It appeared to me that things like DMAIC and PDCA are not exactly core concepts of a medical curriculum.
 
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