MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-04-19 for ER manufactured by Bte Technologies, Inc..
[3347277]
Trained operator of bte equipment was setting up the device to perform a physical capability test of a potential employee of a food distribution company. The operator failed to properly secure a handle that is part of the device. The operator pulled on the handle to test the setup. The handle came out and the operator fell backward. The operator had bruise on the arm where the handle hit it and soreness in the back. X-ray was performed and anti-inflammatory medicine given. The doctor diagnosed it as a mild concussion and cervical stress. One person, the operator, was involved in the incident. No patients were involved.
Patient Sequence No: 1, Text Type: D, B5
[10777653]
It is bte policy to report to the fda any event involving bte products that we became aware of where patient or user required medical intervention by medical personnel. This report is submitted because the equipment operator was examined by a doctor.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119903-2013-00001 |
| MDR Report Key | 3075141 |
| Report Source | 06 |
| Date Received | 2013-04-19 |
| Date of Report | 2013-04-18 |
| Date of Event | 2013-03-20 |
| Date Mfgr Received | 2013-03-22 |
| Device Manufacturer Date | 2001-09-28 |
| Date Added to Maude | 2013-05-07 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | EWA KACZANOWSKA, MANAGER |
| Manufacturer Street | 7455-L NEW RIDGE RD. |
| Manufacturer City | HANOVER MD 21076 |
| Manufacturer Country | US |
| Manufacturer Postal | 21076 |
| Manufacturer Phone | 4108500333 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ER |
| Product Code | IKK |
| Date Received | 2013-04-19 |
| Returned To Mfg | 2013-04-05 |
| Model Number | ER |
| Operator | OTHER |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BTE TECHNOLOGIES, INC. |
| Manufacturer Address | HANOVER MD US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-04-19 |