STORZ DAVIS DOUBLE BITE MOUTH GAG N7451

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-01-10 for STORZ DAVIS DOUBLE BITE MOUTH GAG N7451 manufactured by Storz Instrument Co..

Event Text Entries

[55307] This mouth gag broke during a procedure. Another mouth gag was used.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1932180-1997-90001
• MDR Report Key: 86604
• Report Source: 06
• Date Received: 1997-01-10
• Date of Report: 1996-12-11
• Date of Event: 1996-12-11
• Date Facility Aware: 1996-12-11
• Report Date: 1996-12-11
• Date Reported to Mfgr: 1996-12-11
• Date Mfgr Received: 1996-12-11
• Date Added to Maude: 1997-04-29
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 3
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: STORZ DAVIS DOUBLE BITE MOUTH GAG
• Generic Name: MOUTH GAG
• Product Code: KBN
• Date Received: 1997-01-10
• Model Number: NA
• Catalog Number: N7451
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: UNKNOWN
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 85790
• Manufacturer: STORZ INSTRUMENT CO.
• Manufacturer Address: 499 SOVEREIGN CT. ST. LOUIS MO 63011 US
• Baseline Brand Name: STORZ DAVIS DOUBLE BITE MOUTH GAG
• Baseline Generic Name: MOUTH GAG
• Baseline Model No: NA
• Baseline Catalog No: N7451
• Baseline ID: NA
• Baseline Device Family: MOUTH GAG
• Baseline Shelf Life Contained: A
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: Y

Patients

Patient Number	Treatment	Outcome	Date
1	0		1997-01-10