MAUDE Adverse Event Report: PHILIPS PERSONAL HEALTH, A DIVISION OF PHILIPS NORTH AMERICA LLC. PHILIPS AVENT NATURAL RESPONSE BABY BOTTLE NIPPLES; NIPPLE, LAMBS FEEDING

Device Problems Restricted Flow rate (1248); Device Markings/Labelling Problem (2911); Inadequate Instructions for Non-Healthcare Professional (2956); Patient Device Interaction Problem (4001)

Patient Problem Dehydration (1807)

Event Date 04/08/2022

Event Type  Injury  

Event Description

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).

• Brand Name: PHILIPS AVENT NATURAL RESPONSE BABY BOTTLE NIPPLES
• Type of Device: NIPPLE, LAMBS FEEDING
• Manufacturer (Section D): PHILIPS PERSONAL HEALTH, A DIVISION OF PHILIPS NORTH AMERICA LLC.; po box 10313; stamford CT 06904
• MDR Report Key: 14408917
• MDR Text Key: 291840120
• Report Number: MW5109715
• Device Sequence Number: 2
• Product Code: FNN
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 05/12/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1 DA
• Patient Sex: Female
• Patient Weight: 3 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White