MAUDE Adverse Event Report: PHILIPS CONSUMER LIFESTYLE B.V. AVENT NATURAL BABY BOTTLE; BOTTLE, HOT/COLD WATER

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

Patient Problem Weight Changes (2607)

Event Date 05/15/2023

Event Type  Injury  

Event Description

Baby exclusively bottle fed since birth with avent (0 nipple).Weight went from 13.2%tile to 1.74%tile in 9 days.Another words, baby lost 171 grams in 9 days between dol 0 to dol 9.Seen by speech therapist for pediatric feeding dysfunction and was considered for readmission.Changed to dr.(b)(6) bottle level 1.Baby gained 57 grams in 2 days and is at 1.81%tile.

• Brand Name: AVENT NATURAL BABY BOTTLE
• Type of Device: BOTTLE, HOT/COLD WATER
• Manufacturer (Section D): PHILIPS CONSUMER LIFESTYLE B.V.; 6501 living place; pittsburgh PA 15206
• MDR Report Key: 17011087
• MDR Text Key: 316103365
• Report Number: MW5117917
• 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: 05/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PHILIPS AVENT BOTTLE 0: (B)(6) 2023-(B)(6) 2023
• Patient Outcome(s): Life Threatening
• Patient Age: 9 DA
• Patient Sex: Female
• Patient Weight: 3 KG
• Patient Ethnicity: Hispanic