RECTAL THERMOMETER *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-15 for RECTAL THERMOMETER * manufactured by Faichney Medical Co..

Event Text Entries

[102443] Submitted an mdr on june 11, 1997.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4001949
• MDR Report Key: 105596
• Date Received: 1997-07-15
• Date of Report: 1997-07-15
• Date Added to Maude: 1997-07-17
• 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: RECTAL THERMOMETER
• Generic Name: THERMOMETER
• Product Code: FLK
• Date Received: 1997-07-15
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: 1933255
• Operator: LAY USER/PATIENT
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 103826
• Manufacturer: FAICHNEY MEDICAL CO.
• Manufacturer Address: 11611 FAIRGROVER INDUSTRIAL MARYLAND HTS MO 63043 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1997-07-15