STERI-GAS 4-100 CARTRIDGE

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 2000-09-19 for STERI-GAS 4-100 CARTRIDGE manufactured by 3m.

Event Text Entries

[20681614] Several employees of hosp have presented elevated liver enzymes which they atrribute to exposure to ethylene oxide.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2110898-2000-00013
• MDR Report Key: 297906
• Report Source: 06
• Date Received: 2000-09-19
• Date of Report: 2000-09-15
• Date Mfgr Received: 2000-03-30
• Date Added to Maude: 2000-09-28
• 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
• Manufacturer Contact: GAIL STEWARD
• Manufacturer Street: 3M CENTER BLDG. 275-5W-06 PO BOX 33275
• Manufacturer City: ST. PAUL MN 551333275
• Manufacturer Country: US
• Manufacturer Postal: 551333275
• Manufacturer Phone: 6517369057
• 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: STERI-GAS 4-100 CARTRIDGE
• Generic Name: EO GAS CARTRIDGE
• Product Code: FLI
• Date Received: 2000-09-19
• Model Number: NA
• Catalog Number: 4-100
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 288364
• Manufacturer: 3M
• Manufacturer Address: 3M CENTER, BLDG. 275-5W-06 PO BOX 33275 ST. PAUL MN 551333275 US
• Baseline Brand Name: STERI-GAS
• Baseline Generic Name: EO GAS CATRIDGE
• Baseline Model No: NA
• Baseline Catalog No: 4-100
• Baseline ID: *
• Baseline Device Family: STERILIZATION HARDWARE
• Baseline Shelf Life [Months]: NA
• 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	1. Other	2000-09-19