BAXTER *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-12 for BAXTER * manufactured by Pond's (india) Limited, Initial Importer/distributor: Faichney Med Co..

Event Text Entries

[56446] Consumer alleges that the bulb of the thermometer broke off in his infant daughter's rectum after taking a rectal temperature. The infant was taken to hosp where bowel movements were induced, which successfully cleared the thermometer tip from the rectum. The infant was discharged within 3-4 hrs with no further treatment, and has since been seen by a dr and no further problems or treatment was necessary. This report is submitted by faichney medical co ("faichney") based on info received by faichney, which faichney may or may not have had an opportunity to investigate or verify prior to submission of this report. This report shall not be construed as an admission by faichney (a) that the product described herein was mfg, imported, or distributed by faichney; (b) that any causal relationship exists between such product and any actual or potential injury; or (c) that any reportable event has in fact occurred.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1933255-1997-00007
• MDR Report Key: 97941
• Date Received: 1997-06-12
• Date of Report: 1997-06-11
• Date of Event: 1997-05-26
• Date Facility Aware: 1997-06-04
• Report Date: 1997-06-11
• Date Reported to FDA: 1997-06-11
• Date Reported to Mfgr: 1997-06-12
• Date Added to Maude: 1997-06-17
• 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
• Reporter Occupation: UNKNOWN
• 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: 1997-06-12
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 96587
• Manufacturer: POND'S (INDIA) LIMITED, INITIAL IMPORTER/DISTRIBUTOR: FAICHNEY MED CO.
• Manufacturer Address: 11611 FAIRGROVE INDUSTRIAL BLVD. MARYLAND HGTS MO 63043 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1997-06-12