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 1996-10-25 for MOUTH GAG * manufactured by Dittman & Penn Corp..

Event Text Entries

[24529] Mouth gag broke on placement in pt's mouth. Pt required sutures.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1010155
• MDR Report Key: 44764
• Date Received: 1996-10-25
• Date of Report: 1996-10-07
• Date of Event: 1996-10-03
• Date Added to Maude: 1996-10-29
• 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: MOUTH GAG
• Generic Name: MOUTH GAG
• Product Code: KBN
• Date Received: 1996-10-25
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 45675
• Manufacturer: DITTMAN & PENN CORP.
• Manufacturer Address: 101 E LAUREL AVE PO BOX 66 CHELTENHAM PA 190120066 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1996-10-25