NUK BABY *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-01-09 for NUK BABY * manufactured by Unk.

Event Text Entries

[19902390] While infant sucking on pacifier during diaper change, 11 month old turned pacifier, put pacifier in mouth sideways, and pacifier became lodged in throat causing partial airway obstruction. Described as "road runner".
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1015429
• MDR Report Key: 205926
• Date Received: 1999-01-09
• Date of Report: 1999-01-09
• Date of Event: 1999-01-09
• Date Added to Maude: 1999-01-14
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NUK BABY
• Generic Name: PACIFIER
• Product Code: LQX
• Date Received: 1999-01-09
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: OTHER
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 199893
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention	1999-01-09