MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-25 for AM-BA SERIES TREATMENT TABLE manufactured by Armedica.
[5753928]
Small child was receiving ot treatment for his elbow and was positioned at the side of the armedica hi-lo treatment table. In the course of the treatment, the child depressed the lever control bar resulting in the frame of the bed pinning his legs beneath the table. The downward motion resulted in continuing downward pressure on the control bar resulting in a fracture to his right femur. The child was supervised by the therapist from the opposite side of the treatment table. This was a similar incident filed to the fda on 08/18/2014 with the same model number: am-ba350.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5041722 |
| MDR Report Key | 4645290 |
| Date Received | 2015-03-25 |
| Date of Report | 2015-03-25 |
| Date of Event | 2015-03-18 |
| Date Added to Maude | 2015-04-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AM-BA SERIES TREATMENT TABLE |
| Generic Name | TREATMENT TABLE |
| Product Code | INQ |
| Date Received | 2015-03-25 |
| Model Number | AM-BA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARMEDICA |
| Manufacturer Address | GREENWOOD AR 72936 US 72936 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-03-25 |