MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2002-12-18 for AMSCO 3080 manufactured by Steris Corp.
| Report Number | 1043572-2002-00009 |
| MDR Report Key | 435182 |
| Report Source | 00,06 |
| Date Received | 2002-12-18 |
| Date of Event | 2002-08-29 |
| Date Facility Aware | 2002-08-29 |
| Report Date | 2002-09-10 |
| Date Reported to Mfgr | 2002-11-07 |
| Date Mfgr Received | 2002-11-07 |
| Device Manufacturer Date | 1990-06-01 |
| Date Added to Maude | 2003-01-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ROBERT MCCALL |
| Manufacturer Street | 2720 GUNTER PARK DR E. |
| Manufacturer City | MONTGOMERY AL 36109 |
| Manufacturer Country | US |
| Manufacturer Postal | 36109 |
| Manufacturer Phone | 3342133150 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMSCO 3080 |
| Product Code | FSE |
| Date Received | 2002-12-18 |
| Device Age | 12 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 405373 |
| Manufacturer | STERIS CORP |
| Manufacturer Address | 2720 GUNTER PARK DRIVE E MONTGOMERY AL 36109 US |
| Baseline Brand Name | AMSCO 3080 |
| Baseline Generic Name | OR TABLE |
| Baseline Model No | 3080 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-12-18 |