WALGREEN'S *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-02-14 for WALGREEN'S * manufactured by Pond's (india) Ltd..

Event Text Entries

[40894] Customer corresponded that the bulb of the oral thermometer broke in their child's mouth, resulting in the possible ingestion of mercury and the thermometer bulb. Dist was made aware of the incident 1/31/97, but received no specific info until 2/3/97. The complainant reported that the child is seeing a physician due to neuromuscular movements. Complainant also reported that the physician is conducting tests, but a diagnosis or cause of problem has not yet been rendered.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1933255-1997-00002
• MDR Report Key: 69298
• Date Received: 1997-02-14
• Date of Report: 1997-02-14
• Date of Event: 1996-11-01
• Date Facility Aware: 1997-01-31
• Report Date: 1997-02-14
• Date Reported to FDA: 1997-02-14
• Date Reported to Mfgr: 1997-02-18
• Date Added to Maude: 1997-02-20
• 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: WALGREEN'S
• Generic Name: ORAL THERMOMETER
• Product Code: FLK
• Date Received: 1997-02-14
• Returned To Mfg: 1997-02-12
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: ITEM #: 671815
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 69261
• Manufacturer: POND'S (INDIA) LTD.
• Manufacturer Address: 11611 FAIRGROVE INDUST BLVD MARYLAND HGTS MO 63043 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1997-02-14