BAXTER BA 4 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-05-01 for BAXTER BA 4 * manufactured by Pond's (india) Ltd..

Event Text Entries

[60017] On 4/22/97, dist received a letter from one of its wholesale customers (who packs the thermometer in "babycare kits" and sells to hospitals) which indicates that when a rectal thermometer was inserted into a male infant, at hosp, that tip of the thermometer broke off inside the infant. The infant was taken to another hosp to have the tip removed. This report is submitted by co based on information received which co may or may not have had the opportunity to investigate or verify prior to submission of this report. This report shall not be construed as an admission by co (a) that the product described herein was mfg, imported, or distributed by co; (b) that any causal relationship exists between such product and any actual or potential injury; or (c) that any reportable event in fact has occurred.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1933255-1997-00004
• MDR Report Key: 88814
• Date Received: 1997-05-01
• Date of Report: 1997-04-29
• Date of Event: 1997-03-29
• Date Facility Aware: 1997-04-22
• Report Date: 1997-04-29
• Date Reported to FDA: 1997-04-29
• Date Reported to Mfgr: 1997-05-01
• Date Added to Maude: 1997-05-07
• Event Key: 0
• Report Source Code: Distributor 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: BAXTER
• Generic Name: THERMOMETER
• Product Code: FLK
• Date Received: 1997-05-01
• Model Number: BA 4
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 87833
• Manufacturer: POND'S (INDIA) LTD.
• Manufacturer Address: * * IN

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	1997-05-01