FDA Adverse Event Injury Summary report: N

AVENT NATURAL BABY BOTTLE

MDR report key: 17011087 · Received May 25, 2023

Report

Report Number
MW5117917
Event Type
Injury
Date Received
May 25, 2023
Date of Event
May 15, 2023
Report Date
May 23, 2023
Manufacturer
PHILIPS CONSUMER LIFESTYLE B.V.
Product Code
FPF
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
650216 AVENT NATURAL BABY BOTTLE BOTTLE, HOT/COLD WATER FPF PHILIPS CONSUMER LIFESTYLE B.V.

Patients

Seq Age Sex Outcome Treatment
1 9 DA Female Life Threatening PHILIPS AVENT BOTTLE 0: (B)(6) 2023-(B)(6) 2023