MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2002-01-18 for STERI-GAS, STERI-VAC * 4-100 manufactured by 3m.
[253320]
Hospital maintainance worker exposed to ethylene oxide gas. Medical attention sought for complaint of irritation to skin, eyes, and respiratory system. Treated by a physician for mild irritation and is currently asymptomatic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2002-00003 |
| MDR Report Key | 374102 |
| Report Source | 01,06 |
| Date Received | 2002-01-18 |
| Date of Report | 2002-01-17 |
| Date of Event | 2001-06-14 |
| Date Added to Maude | 2002-01-30 |
| 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 | JOANN HUEHN |
| Manufacturer Street | 3M CENTER BLDG. 275-5W-06 |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517339209 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERI-GAS, STERI-VAC |
| Generic Name | GAS CARTRIDGE |
| Product Code | FLI |
| Date Received | 2002-01-18 |
| Model Number | * |
| Catalog Number | 4-100 |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 363214 |
| Manufacturer | 3M |
| Manufacturer Address | 3M CENTER, BLDG. 275-5W-06 ST. PAUL MN 551441000 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-01-18 |