FIRST YEARS TEETHER *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-05-10 for FIRST YEARS TEETHER * manufactured by *.

Event Text Entries

[18912312] My son ingested the bacteria in the first years teether that was recalled. He has undergone 2 procedures and more will go on this week. I contacted the co and they are still not reporting any serious illness. There have been leaking reports, bite through, and cuts. My son is still seriously ill. Please help me help other parents regarding the serious reactions of this bacteria that my son ingested. The co has not been forthright with us to date.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1039118
• MDR Report Key: 722848
• Date Received: 2006-05-10
• Date of Report: 2006-05-10
• Date of Event: 2005-09-01
• Date Added to Maude: 2006-06-07
• 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: FIRST YEARS TEETHER
• Generic Name: *
• Product Code: KKO
• Date Received: 2006-05-10
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 711920
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2006-05-10