MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2015-02-18 for PRIMUS (THE BTE WS30) PRIMUSRS (PRRS) manufactured by Bte Technologies, Inc..
[5538582]
No injury was reported. In specific use scenarios one of the primus tools, the chop lift bar, could get accidentally disengaged from the connecting hook that might cause the client to lose balance.
Patient Sequence No: 1, Text Type: D, B5
[12929949]
There is no need to return the device or the device components to bte as the problem is not related to nonconforming parts. The investigation is being conducted using parts from inventory. The problem cannot occur with any other tool or attachment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119903-2015-00001 |
| MDR Report Key | 4531685 |
| Report Source | 01,08 |
| Date Received | 2015-02-18 |
| Date of Report | 2015-01-19 |
| Date of Event | 2015-01-16 |
| Date Mfgr Received | 2015-01-19 |
| Device Manufacturer Date | 2010-08-01 |
| Date Added to Maude | 2015-03-23 |
| 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, REG MANAGER |
| 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 | EXERCISER, MEASURING |
| Product Code | ISD |
| Date Received | 2015-02-18 |
| Model Number | PRIMUSRS (PRRS) |
| 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 | HANOVER MD US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-02-18 |