FDA Adverse Event Injury Summary report: N

PHILIPS AVENT NATURAL RESPONSE BABY BOTTLE NIPPLES

MDR report key: 14408917 · Received May 13, 2022

Report

Report Number
MW5109715
Event Type
Injury
Date Received
May 13, 2022
Date of Event
April 8, 2022
Report Date
May 12, 2022
Manufacturer
PHILIPS PERSONAL HEALTH, A DIVISION OF PHILIPS NORTH AMERICA LLC.
Product Code
FNN
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
AE, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND
Health Professional
*

Narratives

Description of Event or Problem · 0

WE WERE USING PHILIPS AVENT BOTTLES WITH OUR PRECIOUS CHILD AND THEN AGAIN WITH OUR CURRENT CHILD. BETWEEN OUR TWO CHILDREN THE MANUFACTURER CHANGED THE NIPPLES BETWEEN AND ONLY MADE MINOR CHANGES TO THEIR PRODUCT INFORMATION SO THAT IT WAS NOT OBVIOUS THAT THERE WAS A DIFFERENCE IN THEIR PRODUCT. THE NAME OF THE NIPPLE IS "PHILIPS AVENT NATURAL RESPONSE BABY BOTTLE NIPPLES." OUR SECOND CHILD WAS BORN ON APRIL 7 AND WE HAD TO START USING FORMULA 2 DAYS AFTER THE BIRTH UNDER GUIDANCE OF OUR PEDIATRICIAN AND OB. OUR CHILD WAS ONLY EATING 1 OZ OF FORMULA EVERY 3 HOURS AND WAS FEEDING FOR AS LONG AS 1 HOUR STRAIGHT. IT TOOK A COUPLE OF DAYS FOR US TO REALIZE THAT IT WAS DUE TO THE FLOW IN THE NIPPLE ITSELF BEING INCREDIBLY DIFFICULT FOR A NEW BORN TO PRODUCE THE NEEDED SUCTION. WE THEN PURCHASED THE NEXT SIZES UP AND TRIED ALL THE NIPPLES FROM NEWBORN TO 4 FLOW. ALL HAD THE SAME ISSUES. OUR DAUGHTER WAS DEHYDRATION AND REQUIRED ADDITIONAL BILIRUBIN TESTING BECAUSE OF THE DEHYDRATION. OUR PEDIATRICIAN LOOKED AT THE BOTTLES HERSELF AND STATED THAT THEY WERE NOT WORKING AS EXPECTED FOR NEWBORN BOTTLES. OUR DAUGHTER SUFFERED ONLY A LITTLE, HOWEVER THIS COULD BE A HUGE ISSUE FOR FAMILIES THAT ARE NOT AS ATTENTIVE OR SPECIFIC POPULATIONS SUCH AS MOTHERS ON LITHIUM WHERE DEHYDRATION COULD BE CATASTROPHIC. THE VERY VERY MINIMAL CHANGE IN THE PACKAGING CONFOUNDED THIS ISSUE FOR US QUITE A BIT BECAUSE WE WERE EXPECTING THE SAME HIGHER LEVELS OF FLOW FROM THE PRIOR GENERATION OF THEIR PRODUCT; I BELIEVE THE PACKAGING LOOKED IDENTICAL AND THE BOTTLES LOOK IDENTICAL, AND I THINK THE ONLY CHANGE WAS ADDING THE WORDS NATURAL FLOW TO THE TITLE OF THE PRODUCT IN SMALLER TYPE. THANK YOU FOR YOUR REVIEW OF THIS INFORMATION. FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2268534 PHILIPS AVENT NATURAL RESPONSE BABY BOTTLE NIPPLES NIPPLE, LAMBS FEEDING FNN PHILIPS PERSONAL HEALTH, A DIVISION OF PHILIPS NORTH AMERICA LLC.
2268535 PHILIPS AVENT NATURAL RESPONSE BABY BOTTLE NIPPLES NIPPLE, LAMBS FEEDING FNN PHILIPS PERSONAL HEALTH, A DIVISION OF PHILIPS NORTH AMERICA LLC.

Patients

Seq Age Sex Outcome Treatment
1 1 DA Female Other