FDA Adverse Event
Injury
Summary report: N
NUK NEWBORN ORTHODONTIC PACIFIER-EXERCISER
MDR report key: 526483
·
Received May 7, 2004
Report
- Report Number
- MW1032045
- Event Type
- Injury
- Date Received
- May 7, 2004
- Date of Event
- May 7, 2004
- Report Date
- May 7, 2004
- Manufacturer
- MEAD JOHNSON NUTRITIONALS
- Product Code
- LQX
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT WAS DISCOVERED TO HAVE A FINGER CAUGHT IN THE VENT HOLE OF A MEAD JOHNSON NUTRITIONALS NUK NEWBORN ORTHODONTIC PACIFIER-EXERCISER. THE FINGER HAD SWELLED AND CHANGED COLOR, AND THERE WAS DIFFICULTY IN REMOVING THE FINGER DUE TO THE RIGID PLASTIC. BLOOD FLOW RETURNED TO THE FINGER, AND THE SWELLING AND COLOR CHANGE RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUK NEWBORN ORTHODONTIC PACIFIER-EXERCISER | NEWBORN ORTHODONTIC PACIFIER-EXERCISER | LQX | MEAD JOHNSON NUTRITIONALS | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 DAY | Required Intervention |