MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-09 for AMSCO STERIS ARMBOARD NOT APPLICABLE NONE manufactured by Steris Corporation.
[311349]
During surgery the patient's left arm was on an armboard and the armboard collapsed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 551472 |
| MDR Report Key | 551472 |
| Date Received | 2004-09-09 |
| Date of Report | 2004-05-26 |
| Date of Event | 2004-05-19 |
| Report Date | 2004-05-26 |
| Date Reported to FDA | 2004-09-09 |
| Date Added to Maude | 2004-10-27 |
| 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 | AMSCO STERIS ARMBOARD |
| Generic Name | ARMBOARD |
| Product Code | NOD |
| Date Received | 2004-09-09 |
| Model Number | NOT APPLICABLE |
| Catalog Number | NONE |
| Lot Number | NONE |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 540989 |
| Manufacturer | STERIS CORPORATION |
| Manufacturer Address | 2720 GUNTER PARK EAST MONTGOMERY AL 36109 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-09-09 |