MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-02 for SIMULATOR SIMULATOR II SIM II manufactured by Bte Technologies, Inc..
[76742167]
The customer received a replacement tool (attachment) on 5/4/2017 but for over three weeks did not send back to bte the tool involved in the incident. The tool was received at bte on 5/26/2017 leaving bte insufficient time to complete the investigation before 6/2/2017 - thirty days from the incident date. The reported issue only affects one attachment, tool 802, and only this attachment had to be returned to bte. The simulator system performance is not affected. Insufficient time to complete evaluation.
Patient Sequence No: 1, Text Type: N, H10
[76742168]
Patient was using the tool 802 attached to the simulator workhead when the end handle broke from tool, causing her arm to slip in which she then cut her forearm. The patient was taken to the doctor's office. The wound was cleaned and steri-strips were applied. The patient received a tetanus shot and an x-ray was taken to ensure no metal fragments were left in her arm. The patient then returned to clinic to complete functional capacity evaluation (fce) as she stated she felt well enough and wanted to complete the testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119903-2017-00002 |
| MDR Report Key | 6609644 |
| Date Received | 2017-06-02 |
| Date of Report | 2017-05-03 |
| Date of Event | 2017-05-03 |
| Date Mfgr Received | 2017-05-03 |
| Device Manufacturer Date | 2000-10-20 |
| Date Added to Maude | 2017-06-02 |
| 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 |
| Reporter Occupation | OCCUPATIONAL THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. EWA KACZANOWSKA |
| Manufacturer Street | 7455-L NEW RIDGE RD. |
| Manufacturer City | HANOVER MD 21076 |
| Manufacturer Country | US |
| Manufacturer Postal | 21076 |
| Manufacturer Phone | 4108500333 |
| Manufacturer G1 | BTE TECHNOLOGIES, INC. |
| Manufacturer Street | 7455-L NEW RIDGE RD. |
| Manufacturer City | HANOVER MD 21076 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21076 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SIMULATOR |
| Generic Name | SIMULATOR (BTE WORK SIMULATOR) |
| Product Code | BXB |
| Date Received | 2017-06-02 |
| Returned To Mfg | 2017-05-26 |
| Model Number | SIMULATOR II SIM II |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BTE TECHNOLOGIES, INC. |
| Manufacturer Address | 7455-L NEW RIDGE ROAD HANOVER MD 21076 US 21076 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-02 |