BABY CARE KIT BA4 BAXTER INDIA *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-04-15 for BABY CARE KIT BA4 BAXTER INDIA * manufactured by Allegiance-surgical Group.

Event Text Entries

[51147] Glass therometer tip broke off in infant's rectum. Infant transferred to another facility for sigmoidoscopy to remove thermometer tip. X-ray demonstrates complete removal of pieces.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 83705
• MDR Report Key: 83705
• Date Received: 1997-04-15
• Date of Report: 1997-03-31
• Date of Event: 1997-03-29
• Date Facility Aware: 1997-03-31
• Report Date: 1997-03-31
• Date Reported to FDA: 1997-03-31
• Date Reported to Mfgr: 1997-03-31
• Date Added to Maude: 1997-04-16
• 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
• 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: BABY CARE KIT
• Generic Name: BABY CARE KIT
• Product Code: FLK
• Date Received: 1997-04-15
• Model Number: BA4 BAXTER INDIA
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: OTHER
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 83012
• Manufacturer: ALLEGIANCE-SURGICAL GROUP
• Manufacturer Address: 1500 WAUKEGAN RD. MCGRAW IL 60085 US
• Baseline Brand Name: BABY CARE KIT
• Baseline Generic Name: BABY CARE KIT
• Baseline Model No: BAB7-4673
• Baseline Catalog No: BAB7-4673
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	1997-04-15