MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2001-03-01 for STERIS SYSTEM 1 90A1 F1000 manufactured by Steris Corp..
[203341]
In january 2001 steris received notice of an incident in which an operator claims to be suffering from 'reactive airway dysfunction syndrome', which occasionally causes difficulty in breathing, after cleaning up fluid which had spilled from a steris system 1 processor. The event occured in january 1999. The person involved claims to be suffering from 'reactive airway dysfunction syndrome', which occasionally causes difficulty in breathing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1527821-2001-00005 |
| MDR Report Key | 317897 |
| Report Source | 05,06 |
| Date Received | 2001-03-01 |
| Date of Report | 2001-03-01 |
| Date of Event | 1999-01-15 |
| Date Mfgr Received | 2001-01-31 |
| Device Manufacturer Date | 1995-07-01 |
| Date Added to Maude | 2001-03-02 |
| 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 | LAURA GREEN |
| Manufacturer Street | 5960 HEISLEY RD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927013 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERIS SYSTEM 1 |
| Generic Name | STERILE PROCESSING SYSTEM |
| Product Code | MRL |
| Date Received | 2001-03-01 |
| Model Number | 90A1 |
| Catalog Number | F1000 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 307413 |
| Manufacturer | STERIS CORP. |
| Manufacturer Address | 6515 HOPKINS RD. MENTOR OH 44060 US |
| Baseline Brand Name | STERIS SYSTEM 1 |
| Baseline Generic Name | CHEMICAL STERILIZER |
| Baseline Model No | 90A1 |
| Baseline Catalog No | P1000 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2001-03-01 |