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 1997-06-06 for WALGREEN'S * manufactured by Pond's (india) Limited.

Event Text Entries

[64836] Dist was informed of the event by the insurance carrier of the retailer from whom the consumer purchased the therometer. Dist did not receive the facts pertaining to the event until 6/6/97. The consumer alleged that the tip of the rectal thermometer broke while in her daughter's rectum. X-rays were taken, and a sygmoidoscopy was conducted which showed an intestinal abrasion. No further problems were reported following a subsequent examination.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1933255-1997-00006
• MDR Report Key: 96478
• Date Received: 1997-06-06
• Date of Report: 1997-06-06
• Date of Event: 1996-10-13
• Date Facility Aware: 1997-05-06
• Report Date: 1997-06-06
• Date Reported to FDA: 1997-06-06
• Date Reported to Mfgr: 1997-06-10
• Date Added to Maude: 1997-06-10
• 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: WALGREEN'S
• Generic Name: RECTAL FEVER THEROMETER
• Product Code: FLK
• Date Received: 1997-06-06
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: REORDER #671822
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 95250
• Manufacturer: POND'S (INDIA) LIMITED
• Manufacturer Address: 11611 FAIRGROVE INDUSTRIAL BLV MARYLAND HEIGHTS MO 63043 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1997-06-06