REI FIRST AID THERMOMETER D050 407 20 99096

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-04-28 for REI FIRST AID THERMOMETER D050 407 20 99096 manufactured by Hart Health And Safety.

Event Text Entries

[141982] Rptr is the pt. He bought the device, and prior to use he washed it in warm water. As he was washing it, he expected to see the mercury rise, but it did not. He made the water hot, and it still did not rise. He then placed it in his hand with a firm, but not tight grip. Within 15 seconds, the bulb tip broke off and the mercury spilled to the floor. Rptr did not have direct contact with the mercury. While analyzing the glass, the rptr could see where the passage way for the mercury was occluded, preventing it to rise. Rptr is concerned over what could have happened if the device was in someone's mouth at that time. Rptr did not sustain any injury, and has retained the glass portion of the thermometer.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1016205
• MDR Report Key: 220915
• Date Received: 1999-04-28
• Date of Report: 1999-04-28
• Date of Event: 1999-04-26
• Date Added to Maude: 1999-04-29
• 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
• 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: REI
• Generic Name: ORAL THERMOMETER
• Product Code: FLK
• Date Received: 1999-04-28
• Model Number: FIRST AID THERMOMETER
• Catalog Number: D050 407 20 99096
• Lot Number: *
• ID Number: UPIC 407-079-0003
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 214248
• Manufacturer: HART HEALTH AND SAFETY
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-04-28