FDA Adverse Event
Malfunction
Summary report: N
SIMILAC SLOW FLOW NIPPLE AND RING
MDR report key: 6791557
·
Received August 14, 2017
Report
- Report Number
- 6791557
- Event Type
- Malfunction
- Date Received
- August 14, 2017
- Date of Event
- August 2, 2017
- Report Date
- August 3, 2017
- Manufacturer
- ABBOTT NUTRITION ABBOTT LABORATORIES
- Product Code
- FNN
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
INFANT'S FATHER NOTICED DISCOLORATION IN NIPPLE, PRIOR TO BOTTLE FEEDING INFANT. APPEARS TO BE CONSISTENT WITH METAL SHARD. INFANT'S FATHER BROUGHT NIPPLE TO NURSING STAFF AND IT WAS NOT USED WITH INFANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 572375 | SIMILAC SLOW FLOW NIPPLE AND RING | NIPPLE, LAMBS FEEDING | FNN | ABBOTT NUTRITION ABBOTT LABORATORIES | 77071SG00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 YR |