TIMEX *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-12-03 for TIMEX * manufactured by Timex.

Event Text Entries

[19157027] Reporter recently purchased this product and in their opinion it should not be sold on the market. The thermometer did not read the temperature after flexing the tip as indicated on the package. Rptr feels that if it is a good product it should work as noted. Rptr asks if it is even accurate.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1030427
• MDR Report Key: 500958
• Date Received: 2003-12-03
• Date Added to Maude: 2003-12-16
• 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
• 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: TIMEX
• Generic Name: *
• Product Code: FLK
• Date Received: 2003-12-03
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 489728
• Manufacturer: TIMEX
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2003-12-03