Q-TIPS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-04-14 for Q-TIPS * manufactured by Ponds (india) Limited Faichney Med. Co..

Event Text Entries

[48994] Consumer phoned consumer services div. And reported that the bulb broke in her daughter's mouth. The consumer also reported that her daughter was fine and no medical attention was sought.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1933255-1997-00003
• MDR Report Key: 84585
• Date Received: 1997-04-14
• Date of Report: 1997-04-14
• Date of Event: 1997-03-25
• Date Facility Aware: 1997-03-26
• Report Date: 1997-04-14
• Date Reported to FDA: 1997-04-14
• Date Reported to Mfgr: 1997-04-15
• Date Added to Maude: 1997-04-21
• 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: Q-TIPS
• Generic Name: ORAL THERMOMETER
• Product Code: FLK
• Date Received: 1997-04-14
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 83839
• Manufacturer: PONDS (INDIA) LIMITED FAICHNEY MED. CO.
• Manufacturer Address: 11611 FAIRGROVE INDUST. BLVD. MARYLAND HEIGHTS MO 63043 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1997-04-14