MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-21 for AMSCO manufactured by Steris Corporation.
[23701159]
Patient Sequence No: 1, Text Type: N, H10
[23701160]
Bilateral breast implant surgery in progress. Left armboard fell off immediately after bed placed in back up position. Arm slipped out of protective towel/gauze cover. Arm supported immediately by surgeon and then rn. Armboard examined and replaced and arm repositioned. Proper armboard confirmed for the amsco bed in use. Manufacturer response for surgery table armboard, amsco armboard (per site reporter): no response as of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5020756 |
| MDR Report Key | 5020756 |
| Date Received | 2015-08-21 |
| Date of Report | 2015-07-17 |
| Date of Event | 2015-06-30 |
| Report Date | 2015-07-17 |
| Date Reported to FDA | 2015-07-17 |
| Date Reported to Mfgr | 2015-07-17 |
| Date Added to Maude | 2015-08-21 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMSCO |
| Generic Name | ARMBOARD |
| Product Code | FSE |
| Date Received | 2015-08-21 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION |
| Manufacturer Address | 5960 HEISLEY RD. MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-21 |