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 |