RUSCH 204860210

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 2001-09-17 for RUSCH 204860210 manufactured by Rusch.

Event Text Entries

[233452] The customer reports that the blakemore tube had a hole/small tear in the gastric balloon.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9610520-2001-00164
• MDR Report Key: 352298
• Report Source: 06
• Date Received: 2001-09-17
• Date of Report: 2001-09-11
• Date Mfgr Received: 2001-09-10
• Date Added to Maude: 2001-09-21
• 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: DONNA MCLEOD
• Manufacturer Street: 2450 MEADOWBROOK PARKWAY
• Manufacturer City: DULUTH GA 30096
• Manufacturer Country: US
• Manufacturer Postal: 30096
• 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
• Generic Name: FR SENGSTAKEN BLAKE TUBE
• Product Code: FEF
• Date Received: 2001-09-17
• Model Number: NA
• Catalog Number: 204860210
• Lot Number: UNK
• ID Number: NA
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 341575
• Manufacturer: RUSCH
• Manufacturer Address: WILLY RUSCH STRASSE 4-10 KERNEN GM 71394
• Baseline Brand Name: BLAKEMORE TUBE
• Baseline Generic Name: SENGSTAKEN TUBE
• Baseline Model No: NA
• Baseline Catalog No: 204860210
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0		2001-09-17