VALLEYLAB * E2610-6

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-09-05 for VALLEYLAB * E2610-6 manufactured by Valleylab, Inc..

Event Text Entries

[66636] August 26, 1997 - 0815 - tonsillectomy performed with device noted. Cautery unit set at 40 coag. Procedure tolerated well, recovery unevenful. When discharging pt, mother noted something white at the right corner of the mouth and right mid-section of tongue. Dr. Examined child, felt child could still go home. Dr. Saw child on his office the morning of 8/27/97 determined that child had sustained serious burns to right oral cavity involving the roof, tongue, cheek, and corner of lips. Child admitted to hosp afternoon of 8/27/97 in dehydration and obvious pain.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1012039
• MDR Report Key: 117774
• Date Received: 1997-09-05
• Date of Report: 1997-08-28
• Date of Event: 1997-08-26
• Date Added to Maude: 1997-09-09
• Event Key: 0
• Report Source Code: Voluntary 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: VALLEYLAB
• Generic Name: STERILE, DISPASABLE SUCTION COAGULATOR
• Product Code: FEH
• Date Received: 1997-09-05
• Model Number: *
• Catalog Number: E2610-6
• Lot Number: 17023 MFG APR 93
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 115504
• Manufacturer: VALLEYLAB, INC.
• Manufacturer Address: 5920 LONGBOW DR. BOULDER CO 80301 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other; 3. Required No Informationntervention	1997-09-05