STORZ MOUTH GAG *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-08-16 for STORZ MOUTH GAG * manufactured by Storz Instrument Company.

Event Text Entries

[19897992] Patient undergoing an adenoidectomy with a mouth gag in place. A piece of the mouth gag broke off and landed in the surgeon's lap. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 543509
• MDR Report Key: 543509
• Date Received: 2004-08-16
• Date of Report: 2004-08-16
• Date of Event: 2004-08-12
• Report Date: 2004-08-16
• Date Reported to FDA: 2004-08-16
• Date Added to Maude: 2004-09-16
• Event Key: 0
• Report Source Code: User Facility 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: STORZ MOUTH GAG
• Generic Name: MOUTH GAG
• Product Code: KBN
• Date Received: 2004-08-16
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 532899
• Manufacturer: STORZ INSTRUMENT COMPANY
• Manufacturer Address: SUBSIDIARY OF BAUSCH LOMB 3365 TREE COURT INDUSTRIAL BOU SAINT LOUIS MO 63122 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-08-16