FIRST YEARS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-04-21 for FIRST YEARS * manufactured by First Years.

Event Text Entries

[445310] Pt has been diagnosed with pseudomonas aeruginosa due to possible ingestion of fluid from a recalled first yrs animal teether. Before diagnosis, complainant stated that his son was using an animal teether mfg by first yrs. Complainant stated that his son bit into the teether about four months ago and he noticed the liquid missing. He contacted posion control, who informed him that the liquid inside the teether was non-toxic. Since that time, his son has been in and out of the hosp due to continuous coughing. During the last visit to the hosp, his son was diagnosed with the above bacteria. Upon reading the local newspaper over the weekend, the complainant realized the first yrs teether he had purchased for his son was involved in a recall. His son will be starting the antibiotic cipro.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4004163
• MDR Report Key: 707946
• Date Received: 2006-04-21
• Date of Report: 2006-01-30
• Date of Event: 2006-01-01
• Date Added to Maude: 2006-05-05
• 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: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: FIRST YEARS
• Generic Name: ANIMAL TEETHER
• Product Code: KKO
• Date Received: 2006-04-21
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 696999
• Manufacturer: FIRST YEARS
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening	2006-04-21