MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2000-05-19 for STERI-GAS 4-100 CARTRIDGE manufactured by 3m Co..
[151274]
Customer was preparing to operate eto sterilizer. Customer removed a cartridge from its carton in a wall mounted storage cabinet. Customer claimed that cartridge appeared to be leaking. Customer immediately dropped the cartridge on the floor, left the room, closed the door and notified administration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2000-00004 |
| MDR Report Key | 278744 |
| Report Source | 01,05,07 |
| Date Received | 2000-05-19 |
| Date of Report | 2000-04-10 |
| Date Mfgr Received | 1999-08-19 |
| Date Added to Maude | 2000-05-24 |
| 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 | 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 |
| Brand Name | STERI-GAS 4-100 CARTRIDGE |
| Generic Name | EO GAS CARTRIDGE |
| Product Code | FLI |
| Date Received | 2000-05-19 |
| 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 | 269760 |
| Manufacturer | 3M CO. |
| Manufacturer Address | 3M CENTER, BLDG. 275-3E-08 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-05-19 |