FEVER THERMOMETER 3303 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1999-08-26 for FEVER THERMOMETER 3303 * manufactured by The First Years.

Event Text Entries

[20760933] Tip of glass thermometer was broken off prior to rectal use. Tip and mercury was found in thermometer case. Child was taken to medical dr for examination. No injury noted.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1217805-1999-00002
• MDR Report Key: 237821
• Report Source: 04
• Date Received: 1999-08-26
• Date of Report: 1999-07-16
• Date of Event: 1999-07-16
• Date Mfgr Received: 1999-07-16
• Date Added to Maude: 1999-09-01
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: FEVER THERMOMETER
• Generic Name: MERCURY IN GLASS THERMOMETER
• Product Code: FLK
• Date Received: 1999-08-26
• Returned To Mfg: 1999-03-03
• Model Number: 3303
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 230466
• Manufacturer: THE FIRST YEARS
• Manufacturer Address: ONE KIDDIE DR. AVON MA 02322 US
• Baseline Brand Name: FEVER THERMOMETER
• Baseline Generic Name: MERCURY IN GLASS THERMOMETER
• Baseline Model No: 3303
• Baseline Catalog No: *
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-08-26