MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-05-23 for GENDEX EXPERT DC 0.822.5214 EXPERT DC65 NA manufactured by Gendex Dental Systems.
[147340658]
An investigation was conducted using interviews and examining three photos of the unit, lag bolts, and wall where it had been attached. It appears that the top bolt came out of the wall and the bottom bolt was bent from the weight of the unit. A root cause could not be determined; however, it appears that the unit had been moved since the initial installation. The re-install may have diminished the wall stud integrity to support the unit. Sales of the expert dc were discontinued on june 24, 2016. This concludes the investigation.
Patient Sequence No: 1, Text Type: N, H10
[147340659]
It was reported that the unit fell off the wall. It was reported that unit was caught by the hygienist and hit the patient in the leg, but there was no injury reported for the patient or the operator (hygienist). Unit was reattached to the wall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530069-2019-00004 |
| MDR Report Key | 8638116 |
| Report Source | OTHER |
| Date Received | 2019-05-23 |
| Date of Report | 2019-05-23 |
| Date of Event | 2019-05-07 |
| Date Mfgr Received | 2019-05-07 |
| Device Manufacturer Date | 2010-01-01 |
| Date Added to Maude | 2019-05-23 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ERIKA MARTIN |
| Manufacturer Street | 1910 NORTH PENN ROAD |
| Manufacturer City | HATFIELD PA 19440 |
| Manufacturer Country | US |
| Manufacturer Postal | 19440 |
| Manufacturer G1 | GENDEX DENTAL SYSTEMS |
| Manufacturer Street | 1910 NORTH PENN ROAD |
| Manufacturer City | HATFIELD PA 19440 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19440 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENDEX EXPERT DC |
| Generic Name | EXTRAORAL SOURCE X-RAY SYSTEM |
| Product Code | EHD |
| Date Received | 2019-05-23 |
| Model Number | 0.822.5214 |
| Catalog Number | EXPERT DC65 NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENDEX DENTAL SYSTEMS |
| Manufacturer Address | 1910 NORTH PENN ROAD HATFIELD PA 19440 US 19440 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-23 |