MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-06-02 for GXDP-300 900714 manufactured by Palodex Group Oy.
[76523300]
At the receipt of this report, the initial reporter indicated that the digital panoramic x-ray unit gxdp-300 (serial # (b)(4)) was installed at his dental office on (b)(6) 2016. During the training, several employees at the dental office commented the pitch and volume of the exposure warning speaker was excessive. According to the initial reporter, cotton and tape were used to reduce the volume of the warning speaker. However, one employee of the dental office complained that the noise of the exposure warning speaker has resulted in a consistent ringing in her ears despite the initial reporter's attempts to temper the loudness of the alarm. It was reported that the employee has met several doctors and has been told that the ringing in her ears will be permanent. Investigation by the manufacturer is underway, and a supplemental report will be filed after completion of the investigation. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[76523301]
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 | 3005383085-2017-00001 |
| MDR Report Key | 6607945 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-06-02 |
| Date of Report | 2017-11-13 |
| Date of Event | 2017-05-05 |
| Date Mfgr Received | 2017-05-05 |
| Device Manufacturer Date | 2016-09-23 |
| Date Added to Maude | 2017-06-02 |
| 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANNI LUNDHOLM |
| Manufacturer Street | NAHKELANTIE 160 |
| Manufacturer City | TUUSULA, 00430 |
| Manufacturer Country | FI |
| Manufacturer Postal | 00430 |
| Manufacturer Phone | 5810270200 |
| Manufacturer G1 | PALODEX GROUP OY |
| Manufacturer Street | NAHKELANTIE 160 |
| Manufacturer City | TUUSULA, 00430 |
| Manufacturer Country | FI |
| Manufacturer Postal Code | 00430 |
| 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 | DENTIST |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PALODEX GROUP OY |
| Manufacturer Address | NAHKELANTIE 160 TUUSULA, 00430 FI 00430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2017-06-02 |