* 12344

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-05-17 for * 12344 manufactured by Armstrong, Medical Ltd..

MAUDE Entry Details

• Report Number: 9616692-2001-00007
• MDR Report Key: 334227
• Report Source: 05
• Date Received: 2001-05-17
• Date of Event: 2000-12-01
• Date Mfgr Received: 2001-04-20
• Date Added to Maude: 2001-05-24
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: FRANK POKROP ASSOCIATE DIRECTOR
• Manufacturer Street: 200 ABBOTT PARK RD DE. 37K BLDG. J-45
• Manufacturer City: ABBOTT PARK IL 600646132
• Manufacturer Country: US
• Manufacturer Postal: 600646132
• Manufacturer Phone: 8479378473
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: *
• Product Code: CBL
• Date Received: 2001-05-17
• Model Number: *
• Catalog Number: 12344
• Lot Number: *
• ID Number: *
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 323570
• Manufacturer: ARMSTRONG, MEDICAL LTD.
• Manufacturer Address: WATTSTOWN BUSINESS PARK NEWBRIDGE RD. COLERAINE EI
• Baseline Brand Name: AMSORB 1K CARTRIDGES
• Baseline Generic Name: CARBON DIOXIDE ABSORBENT
• Baseline Model No: NA
• Baseline Catalog No: 12344
• Baseline Device Family: NA
• Baseline Shelf Life Contained: *
• Baseline Shelf Life [Months]: *
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0		2001-05-17