TRIPLE-PORT GASTROSTOMY TUBE E3316

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 1998-09-23 for TRIPLE-PORT GASTROSTOMY TUBE E3316 manufactured by Rusch, Inc..

Event Text Entries

[114597] The catheter balloon burst.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2429473-1998-00061
• MDR Report Key: 189021
• Report Source: 01,08
• Date Received: 1998-09-23
• Date of Report: 1998-09-22
• Date Mfgr Received: 1998-08-14
• Date Added to Maude: 1998-09-28
• 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
• Single Use: 3
• Remedial Action: IN
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TRIPLE-PORT GASTROSTOMY TUBE
• Generic Name: GASTROSTOMY CATHETERS
• Product Code: KDH
• Date Received: 1998-09-23
• Model Number: NA
• Catalog Number: E3316
• 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: 183684
• Manufacturer: RUSCH, INC.
• Manufacturer Address: 2450 MEADOWBROOK PKWY. DULUTH GA 30136 US
• Baseline Brand Name: TRIPLE-PORT GASTROSTOMY CATHETERS
• Baseline Generic Name: GASTROSTOMY CATHETER
• Baseline Model No: NA
• Baseline Catalog No: E3316
• Baseline ID: NA
• Baseline Device Family: GASTROSTOMY CATHETER
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K891371
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1998-09-23