MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-06-03 for STERIS AMSCO UNK manufactured by Steris Co..
[141701]
Ethylene canister leaked in "csr". Employee had one spot on her. No injury to the employee. Seen in er, no known injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 225725 |
| MDR Report Key | 225725 |
| Date Received | 1999-06-03 |
| Date of Report | 1999-05-26 |
| Date of Event | 1999-05-25 |
| Date Facility Aware | 1999-05-25 |
| Report Date | 1999-05-26 |
| Date Reported to FDA | 1999-06-01 |
| Date Added to Maude | 1999-06-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERIS AMSCO |
| Generic Name | ETO CANISTER |
| Product Code | FLF |
| Date Received | 1999-06-03 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Device Availability | * |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 218891 |
| Manufacturer | STERIS CO. |
| Manufacturer Address | 5960 HEISLEY RD. MENTOR OH 44060 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1999-06-03 |