RUSCH ESOPHAGEAL BOUGIE, 56FR 215056

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-11-01 for RUSCH ESOPHAGEAL BOUGIE, 56FR 215056 manufactured by Rusch, Inc..

Event Text Entries

[252786] Bougie cracked.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2429473-2002-00211
• MDR Report Key: 426382
• Report Source: 05,06
• Date Received: 2002-11-01
• Date of Report: 2002-10-25
• Date Mfgr Received: 2002-10-07
• Date Added to Maude: 2002-11-08
• 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: 0
• Manufacturer Contact: NICOLE BLACKMAN, COORDINATOR
• Manufacturer Street: 2450 MEADOWBROOK PARKWAY
• Manufacturer City: DULUTH GA 30136
• Manufacturer Country: US
• Manufacturer Postal: 30136
• Manufacturer Phone: 7706230816
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: RUSCH ESOPHAGEAL BOUGIE, 56FR
• Generic Name: ESOPHAGEAL/GASTROENTEROLOGY
• Product Code: FAT
• Date Received: 2002-11-01
• Model Number: NA
• Catalog Number: 215056
• Lot Number: UNK
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 415430
• Manufacturer: RUSCH, INC.
• Manufacturer Address: 2450 MEADOWBROOK PKWY. DULUTH GA 30096 US
• Baseline Brand Name: RUSCH ESOPHAGEAL BOUGIE, 56FR
• Baseline Generic Name: ESOPHAGEAL/GASTROENTEROLOGY
• Baseline Model No: NA
• Baseline Catalog No: 215056
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0		2002-11-01