RUSCH E-196

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2002-05-16 for RUSCH E-196 manufactured by Rusch Inc. Manufacturing (uk).

Event Text Entries

[16291432] Customer reports holes in the bags.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8010092-2002-00100
• MDR Report Key: 395566
• Report Source: 08
• Date Received: 2002-05-16
• Date of Report: 2002-05-15
• Date Mfgr Received: 2002-05-15
• Date Added to Maude: 2002-05-23
• 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: ROLANDA SCOTT, DOCUMENT CONTROL
• 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: NEOPRENE PECAN BAG
• Product Code: BYW
• Date Received: 2002-05-16
• Model Number: NA
• Catalog Number: E-196
• Lot Number: 1J260, 1J267
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 384572
• Manufacturer: RUSCH INC. MANUFACTURING (UK)
• Manufacturer Address: PORTADOWN ROAD, LURGAN CRAIGAVON CO. ARMAGH, N. IRELAND UK BT66 8RD
• Baseline Brand Name: NEOPRENE PECAN BAG
• Baseline Model No: NA
• Baseline Catalog No: E-196
• Baseline ID: NA
• Baseline Device Family: ANESTHESIA
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: Y

Patients

Patient Number	Treatment	Outcome	Date
1	0		2002-05-16