MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-04-05 for DENOPTIX QST DIGITAL IMAGING SYSTEM 2011043335 0.822.0725 manufactured by Alara, Inc..
[2689592]
Nurse got electric shock while she put the drum into the denoptix, there was no pt involved but the nurse got electric shock 3 times.
Patient Sequence No: 1, Text Type: D, B5
[9956390]
Awaiting investigation results; product unlikely to be returned. Upon completion of investigation, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2530069-2012-00007 |
| MDR Report Key | 2542937 |
| Report Source | 01,07 |
| Date Received | 2012-04-05 |
| Date of Report | 2012-04-05 |
| Date of Event | 2011-10-26 |
| Date Mfgr Received | 2011-10-26 |
| Date Added to Maude | 2012-09-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELIZABETH LAZARO |
| Manufacturer Street | 1910 NORTH PENN RD. |
| Manufacturer City | HATFIELD PA 19440 |
| Manufacturer Country | US |
| Manufacturer Postal | 19440 |
| Manufacturer Phone | 2679540365 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DENOPTIX QST DIGITAL IMAGING SYSTEM |
| Generic Name | DENTAL IMAGING PROCESSOR |
| Product Code | EGY |
| Date Received | 2012-04-05 |
| Model Number | 2011043335 |
| Catalog Number | 0.822.0725 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALARA, INC. |
| Manufacturer Address | 47505 SEABRIDGE DR. ALAMEDIA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-05 |