MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-08-17 for PRIMUS PRIMUS+ manufactured by Bte Technologies, Inc..
[82959645]
The root cause of the incident is user error: the operator lost balance and stumbled.
Patient Sequence No: 1, Text Type: N, H10
[82959646]
While attempting to calibrate the primus, the physical therapist missed the slot in the calibration bar where the calibration weight should be hung and lost balance. She hit her face on the calibration bar or weight, breaking her nose. She required surgery at the er and missed a few days of work. After returning to work, the therapist called bte customer support with questions regarding the equipment, she then described the incident. She stated that she was doing well and was suffering no ill effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119903-2017-00003 |
| MDR Report Key | 6802106 |
| Report Source | USER FACILITY |
| Date Received | 2017-08-17 |
| Date of Report | 2017-07-25 |
| Date of Event | 2017-07-11 |
| Date Mfgr Received | 2017-07-25 |
| Device Manufacturer Date | 2015-05-07 |
| Date Added to Maude | 2017-08-17 |
| 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 | PHYSICAL 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRIMUS |
| Generic Name | PRIMUS |
| Product Code | ISD |
| Date Received | 2017-08-17 |
| Model Number | PRIMUS+ |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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. Required No Informationntervention | 2017-08-17 |