TUM-E-VAC EASY-GLIDE GASTRIC LAVAGE TUBE 2136 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-08-14 for TUM-E-VAC EASY-GLIDE GASTRIC LAVAGE TUBE 2136 * manufactured by Ethox Corp..

Event Text Entries

[259634] Pt came in as overdose from pain medications. Md ordered insertion of lavage tube with charcoal to be administered after the saline flush. Pt tolerated all without difficulty. No difficulty with insertion either. After charcoal instilled and lavage tube removed, approx an hour later, pt reported chest pain. Chest film indicated esophageal perforation. Pt sent to o. R emergently and hospitalized for approx one week. No problems noted during stay. Pt went on home with naso-gastric tube in place and strict orders not to eat/drink via mouth/throat/esophagus.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 411705
• MDR Report Key: 411705
• Date Received: 2002-08-14
• Date of Report: 2002-07-16
• Date of Event: 2002-06-25
• Date Facility Aware: 2002-06-26
• Report Date: 2002-07-16
• Date Reported to Mfgr: 2002-07-15
• Date Added to Maude: 2002-08-22
• 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 Sequence Number: 1

• Brand Name: TUM-E-VAC EASY-GLIDE GASTRIC LAVAGE TUBE
• Generic Name: LAVAGE TUBE #2136 36FR
• Product Code: KDH
• Date Received: 2002-08-14
• Model Number: 2136
• Catalog Number: *
• Lot Number: 1112510
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 400718
• Manufacturer: ETHOX CORP.
• Manufacturer Address: * BUFFALO NY 14204 US

Device Sequence Number: 2

• Brand Name: TUM-E-VAC EASY-GLIDE LAVAGE TUBE
• Generic Name: LAVAGE TUBE #2136 36 FR
• Product Code: KDH
• Date Received: 2002-08-14
• Model Number: 2055
• Catalog Number: *
• Lot Number: 1112510
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 400719
• Manufacturer: ETHOX CORP.
• Manufacturer Address: * BUFFALO NY 14204 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2002-08-14