BAXTER BABY INFANT KIT FNF 105 X

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-17 for BAXTER BABY INFANT KIT FNF 105 X manufactured by Faicheny Medical Co..

Event Text Entries

[20839] Pt brought into er by rescue on 6/7/96. Parents stated while taking rectal temp, mercury rectal thermometer broke off at the end of rectal bulb into the pt's rectum.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 35673
• MDR Report Key: 35673
• Date Received: 1996-07-17
• Date of Report: 1996-06-07
• Date of Event: 1996-06-07
• Date Facility Aware: 1996-06-07
• Report Date: 1996-06-27
• Date Reported to Mfgr: 1996-06-28
• Date Added to Maude: 1996-08-22
• Event Key: 0
• Report Source Code: User Facility 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: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BAXTER BABY INFANT KIT
• Generic Name: MERCURY THERMOMETER
• Product Code: FLK
• Date Received: 1996-07-17
• Model Number: NA
• Catalog Number: FNF 105 X
• Lot Number: NA
• ID Number: NA
• Operator: OTHER
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 35897
• Manufacturer: FAICHENY MEDICAL CO.
• Manufacturer Address: 17159 SURREY U DR CHESTERFIELD MO 63005 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1996-07-17