RVSCH * 205100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-07-06 for RVSCH * 205100 manufactured by Rusch Inc..

Event Text Entries

[126412] Cantor tube inserted mercury instilled. X-ray revealed mercury in stomach 10/7/98 mfr sent more thorough instructions for insertion.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 232594
• MDR Report Key: 232594
• Date Received: 1999-07-06
• Date of Report: 1999-07-06
• Date of Event: 1998-09-20
• Report Date: 1999-07-06
• Date Added to Maude: 1999-07-23
• 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
• Reporter Occupation: RISK MANAGER
• 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: RVSCH
• Generic Name: CANTOR TUBE
• Product Code: FEI
• Date Received: 1999-07-06
• Model Number: *
• Catalog Number: 205100
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 224744
• Manufacturer: RUSCH INC.
• Manufacturer Address: 2450 MEADOW BROOK PKWY DULUTH GA 30136 US
• Baseline Brand Name: CANTOR TUBE
• Baseline Generic Name: INTESTINAL TUBE
• Baseline Model No: NA
• Baseline Catalog No: 205100
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	1999-07-06