MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2000-10-27 for STERI-GAS UNK manufactured by 3m.
[20886373]
Individual reported exposure to ehtylene oxide.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2000-00014 |
| MDR Report Key | 302343 |
| Report Source | 00 |
| Date Received | 2000-10-27 |
| Date of Report | 2000-10-23 |
| Date of Event | 1999-01-31 |
| Date Added to Maude | 2000-11-01 |
| 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 | 3 |
| Manufacturer Contact | JOANN HUEHN |
| Manufacturer Street | 3M CENTER BLDG. 275-5W06 PO BOX 33275 |
| Manufacturer City | ST. PAUL MN 551333275 |
| Manufacturer Country | US |
| Manufacturer Postal | 551333275 |
| 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 |
| Generic Name | ETHYLENE OXIDE GAS CARTRIDGE |
| Product Code | FLF |
| Date Received | 2000-10-27 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 292635 |
| Manufacturer | 3M |
| Manufacturer Address | 3M CENTER, BLDG. 275-5W-06 PO BOX 33275 ST. PAUL MN 551333275 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-10-27 |