THE FIRST YEARS 3033 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-06-23 for THE FIRST YEARS 3033 * manufactured by *.

Event Text Entries

[226701] While shaking down a "the first years" thermometer, there was a mercury leak, and user abruptly moved newborn to avoid being contaminated with mercury. As user removed the second "the first years" thermometer from its plastic sheath, the end cap broke off and mercury contaminated household items. User is extremely concerned with this product, as it happened twice in a row, and user would not dare to imagine the disaster that would have occurred if this end cap would have broken off in newborn, or to think of mercury poisoning. User returned to the store and the mgr contacted co about these thermometers and a customer rep informed mfr that user was to send the thermometers back to their co and informed mgr that she is to have user contact the fda to be told that the amount of mercury in their thermometer is not at all harmful to infants. Obviously, if god wanted infants to have mercury in their systems to that extend, he would have put it there and not the first years co. It is user's intent as parents to be assured that this product be removed from shelves until it can be guaranteed safe.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1022261
• MDR Report Key: 339423
• Date Received: 2001-06-23
• Date of Report: 2001-06-23
• Date of Event: 2001-06-20
• Date Added to Maude: 2001-06-29
• 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
• 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: THE FIRST YEARS
• Generic Name: THERMOMETER #3033
• Product Code: FLK
• Date Received: 2001-06-23
• Model Number: 3033
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 328749
• Manufacturer: *
• Manufacturer Address: * AVON MA 023221177 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2001-06-23