MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-02 for GXDP-300 900714 manufactured by Palodex Group Oy.
[76523692]
It was reported that the volume of exposure warning speaker of a digital panoramic x-ray unit gxdp-300 (serial # (b)(4)) is too loud, and has allegedly contributed to an operator's claim of permanent ringing in ears.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530069-2017-00009 |
| MDR Report Key | 6607953 |
| Date Received | 2017-06-02 |
| Date of Report | 2017-05-05 |
| Date of Event | 2017-05-05 |
| Date Facility Aware | 2017-05-05 |
| Report Date | 2017-06-02 |
| Date Reported to FDA | 2017-06-02 |
| Date Reported to Mfgr | 2017-05-05 |
| Date Added to Maude | 2017-06-02 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GXDP-300 |
| Generic Name | DIGITAL PANORAMIC X-RAY UNIT |
| Product Code | MUH |
| Date Received | 2017-06-02 |
| Model Number | GXDP-300 |
| Catalog Number | 900714 |
| Operator | DENTAL ASSISTANT |
| Device Availability | N |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PALODEX GROUP OY |
| Manufacturer Address | NAHKELANTIE 160 TUUSULA, FI-00430 FI FI-00430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2017-06-02 |