MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2015-07-17 for ARMEDIA MANUFACTURING CORP AMBA334 manufactured by Armedica Mfg. Corp..
[6434906]
Facility report to fda states pt was seated next to armedica table and depressed the motor control causing table to lower injuring his leg.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649977-2015-00002 |
| MDR Report Key | 4925834 |
| Report Source | 00,06 |
| Date Received | 2015-07-17 |
| Date of Report | 2015-07-03 |
| Date of Event | 2015-03-18 |
| Date Mfgr Received | 2015-03-23 |
| Device Manufacturer Date | 2010-04-01 |
| Date Added to Maude | 2015-07-21 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL MCCORMICK |
| Manufacturer Street | 212 BELL RD. |
| Manufacturer City | GREENWOOD AR 72936 |
| Manufacturer Country | US |
| Manufacturer Postal | 72936 |
| Manufacturer Phone | 4799962612 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARMEDIA MANUFACTURING CORP |
| Generic Name | HI-LO TREATMENT TABLE |
| Product Code | INQ |
| Date Received | 2015-07-17 |
| Model Number | AMBA334 |
| Catalog Number | AMBA334 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARMEDICA MFG. CORP. |
| Manufacturer Address | GREENWOOD AR 72936 US 72936 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2015-07-17 |