FDA Adverse Event
Injury
Summary report: N
PHILIPS AVENT BOTTLE 0M+
MDR report key: 17019318
·
Received May 26, 2023
Report
- Report Number
- MW5117939
- Event Type
- Injury
- Date Received
- May 26, 2023
- Date of Event
- May 16, 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 (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 (B)(6) 2022. REFERENCE REPORT: MW5117940.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31640 | PHILIPS AVENT BOTTLE 0M+ | BOTTLE, HOT/COLD WATER | FPF | PHILIPS CONSUMER LIFESTYLE B.V. | 1670296 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 MO | Male | Life Threatening |