TEETHING RING UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-03-02 for TEETHING RING UNK manufactured by First Years.

Event Text Entries

[478092] Infant with one tooth chewed on teething ring. Pt was taken to the er. No adverse event reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1038175
• MDR Report Key: 690716
• Date Received: 2006-03-02
• Date of Report: 2006-03-02
• Date of Event: 2006-03-01
• Date Added to Maude: 2006-03-23
• 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: 3
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND
• 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: TEETHING RING
• Generic Name: *
• Product Code: KKO
• Date Received: 2006-03-02
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 679864
• Manufacturer: FIRST YEARS
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2006-03-02