MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-09-24 for ARMEDICA HI-LO TREATMENT TABLE AM-BA350 NA manufactured by Armedica Mfg. Corp..
[4939760]
Clinic employees daughter inadvertently rested her foot on motor control causing table to lower pinning (and breaking) bone in her leg. The injury not occur during use. Injury was due to non-clinical personnel accidentally activating the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649977-2014-00001 |
| MDR Report Key | 4132582 |
| Report Source | 08 |
| Date Received | 2014-09-24 |
| Date of Report | 2014-08-18 |
| Date of Event | 2014-08-01 |
| Date Mfgr Received | 2014-08-18 |
| Device Manufacturer Date | 2014-05-27 |
| Date Added to Maude | 2014-10-02 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 212 BELL RD. PO BOX 880 |
| Manufacturer City | GREENWOOD AR 72936 |
| Manufacturer Country | US |
| Manufacturer Postal | 72936 |
| Manufacturer Phone | 4799962612 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARMEDICA HI-LO TREATMENT TABLE |
| Generic Name | HI-LO TREATMENT TABLE |
| Product Code | INQ |
| Date Received | 2014-09-24 |
| Model Number | AM-BA350 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARMEDICA MFG. CORP. |
| Manufacturer Address | 212 BELL RD. PO BOX 880 GREENWOOD AR 72936 US 72936 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2014-09-24 |