MAUDE Adverse Event Report: PHILIPS CONSUMER LIFESTYLE B.V. PHILIPS AVENT BOTTLE 0M+; BOTTLE, HOT/COLD WATER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Weight Changes (2607)

Event Date 05/16/2023

Event Type  Injury  

Event Description

Baby exclusively bottle fed since birth with avent (0m+ nipple).Weight went from 93rd percentile to 7th percentile in 6 weeks.Another words, baby gained 230 grams in 40 days between dol (days of life) 3 to dol 43.Changed to grad-u-feed bottle with similac slow flow nipple in outpatient clinic.Baby gained 1 lb 6.9 oz in 7 days and is at 22nd percentile.Lot 1670296.Fab 2022-10-04.Reference report: mw5117939.

• Brand Name: PHILIPS AVENT BOTTLE 0M+
• Type of Device: BOTTLE, HOT/COLD WATER
• Manufacturer (Section D): PHILIPS CONSUMER LIFESTYLE B.V.; 6501 living place; pittsburgh PA 15206
• MDR Report Key: 17019339
• MDR Text Key: 316222650
• Report Number: MW5117940
• Device Sequence Number: 1
• Product Code: FPF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 1 MO
• Patient Sex: Male
• Patient Weight: 4 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White