MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-06-04 for EZ WAY LIGHT STAND S300PN manufactured by Ez Way, Inc..
[5910620]
During a transfer from a chair of a (b)(6) patient in a light stand the end of the actuator cap broke. The patient fell to the floor and bruised her tail bone. She was taken to the hospital and was later released.
Patient Sequence No: 1, Text Type: D, B5
[13318412]
Upon learning of the incident, an ez way representative met with the patient and her family and photographed the light stand. Upon examination, it was found that the folding actuator had not been properly slid into the actuator positioning guide by the end user prior to usage as instructed in the operating manual and as stated on the label directly above the positioning guide. Upon usage, the force of the motor in the incorrect position placed extensive pressure on the actuator, causing it to break. A replacement unit was provided to the patient and the damaged unit was picked up by ez way.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183887-2015-00002 |
| MDR Report Key | 4827924 |
| Report Source | 07 |
| Date Received | 2015-06-04 |
| Date of Report | 2015-06-03 |
| Date of Event | 2015-05-03 |
| Date Mfgr Received | 2015-05-03 |
| Date Added to Maude | 2015-06-10 |
| 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 Contact | MARY LANDHUIS |
| Manufacturer Street | 807 E. MAIN ST. |
| Manufacturer City | CLARINDA IA 51632 |
| Manufacturer Country | US |
| Manufacturer Postal | 51632 |
| Manufacturer Phone | 7125425102 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EZ WAY LIGHT STAND |
| Generic Name | SIT TO STAND |
| Product Code | FNG |
| Date Received | 2015-06-04 |
| Returned To Mfg | 2015-06-01 |
| Model Number | S300PN |
| Catalog Number | S300PN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EZ WAY, INC. |
| Manufacturer Address | CLARINDA IA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-06-04 |