MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-21 for S40 STERILANT manufactured by Steris Corporation - Distribution Center.
| Report Number | 3003950207-2020-00001 |
| MDR Report Key | 9738980 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-01-24 |
| Date Added to Maude | 2020-02-21 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DANIEL DAVY |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR, OH |
| Manufacturer Country | US |
| Manufacturer Phone | 3927453 |
| Manufacturer G1 | STERIS CORPORATION - DISTRIBUTION CENTER |
| Manufacturer Street | 6100 HEISLEY RD |
| Manufacturer City | MENTOR, OH |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | S40 STERILANT |
| Generic Name | S40 STERILANT |
| Product Code | MED |
| Date Received | 2020-02-21 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION - DISTRIBUTION CENTER |
| Manufacturer Address | 6100 HEISLEY RD MENTOR, OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-21 |