MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2012-06-18 for PRIMUS (THE BTE WS30) PRIMUSRS manufactured by Bte Technologies, Inc..
[17606190]
The pt was injured using an attachment (tool 901) during a shovel exercise due to a reported sudden loss of resistance. The exercise was conducted as part of therapy for rupture of the acl, right side. The pt head came in contact with the lever arm of the tool. The pt rec'd three (3) stitches on the forehead. Hospitalization was not required and the individual involved returned to continue treatment at the clinic. His treatment dates are from (b)(6) 2012, several times per week.
Patient Sequence No: 1, Text Type: D, B5
[17751020]
(b)(4). Once bte personnel became aware of the incident it was promptly reviewed, evaluated, and investigated. Bte personnel spoke with the clinic and the device distributor staff several times to inquire about the pt's status. The pt rec'd three (3) stitches on the forehead, did not seek any add'l medical attention and returned to the same clinic to continue therapy. Based on the info obtained, and as unfortunate as this event was, an in view of the definition of serious injury, we did not deem that this met the reporting requirements. It was concluded that the device did not malfunction. In summary, the quality manager believed that none of the criteria for submitting a 30 day report had been met: it was not a serious injury and the device did not malfunction. Consequently, the decision not to file a report with the fda was made.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119903-2012-00001 |
| MDR Report Key | 2625719 |
| Report Source | 00,01 |
| Date Received | 2012-06-18 |
| Date of Report | 2012-02-23 |
| Date of Event | 2012-02-23 |
| Date Mfgr Received | 2012-02-23 |
| Device Manufacturer Date | 2010-08-01 |
| Date Added to Maude | 2012-08-07 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | EWA KACZANOWSKA, QUALITY MGR. |
| Manufacturer Street | 7455-L NEW RIDGE ROAD |
| Manufacturer City | HANOVER MD 21076 |
| Manufacturer Country | US |
| Manufacturer Postal | 21076 |
| Manufacturer Phone | 4108500333 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRIMUS (THE BTE WS30) |
| Generic Name | PRIMUS |
| Product Code | ISD |
| Date Received | 2012-06-18 |
| Model Number | PRIMUSRS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2012-06-18 |