MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-11-27 for NOMAD PRO 2 0.850.0021 manufactured by Aribex.
[93226969]
Upon receipt of the complaint, it was initially determined that this event was not reportable and the battery handset of the unit was replaced. Upon further review of the complaint, it was determined that this is a reportable event. The battery handset subject of the reported incident was discarded by the facility. No evaluation was conducted since the battery handset of the unit has been discarded. This concludes the investigation.
Patient Sequence No: 1, Text Type: N, H10
[93226970]
It was reported that the battery is from 2015 and was sitting in a box not being used. When it was removed from the box, it had burst and has a hole in the side of the casing. There was no report of injuries, user or patient involvement, and no impact to patient care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2017-00066 |
| MDR Report Key | 7061949 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-27 |
| Date of Report | 2017-11-27 |
| Date of Event | 2017-08-21 |
| Date Mfgr Received | 2017-08-21 |
| Device Manufacturer Date | 2015-10-01 |
| Date Added to Maude | 2017-11-27 |
| 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 | DENTAL ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ERIKA MARTIN |
| Manufacturer Street | 11727 FRUEHAUF DRIVE |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal | 28273 |
| Manufacturer Phone | 7045877241 |
| Manufacturer G1 | ARIBEX |
| Manufacturer Street | 11727 FRUEHAUF DRIVE |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 28273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOMAD PRO 2 |
| Generic Name | EXTRAORAL SOURCE X-RAY SYSTEM |
| Product Code | EHD |
| Date Received | 2017-11-27 |
| Model Number | 0.850.0021 |
| Catalog Number | 0.850.0021 |
| Operator | DENTAL ASSISTANT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARIBEX |
| Manufacturer Address | 11727 FRUEHAUF DRIVE CHARLOTTE NC 28273 US 28273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-27 |