MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-08-13 for PROGENY PREVA P7017-P manufactured by Midmark Corp.
[1379902]
A field technician of a dealer reported that the mechanical structure of a preva intra-oral x-ray unit separated from the wall at dr. (b)(6) dental office. The doctor mentioned that the machine struck an employee, but he declined to disclose the employee's name and whether the employee was injured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423380-2010-00028 |
| MDR Report Key | 1812478 |
| Report Source | 08 |
| Date Received | 2010-08-13 |
| Date of Report | 2010-08-06 |
| Date of Event | 2010-07-15 |
| Date Mfgr Received | 2010-07-15 |
| Device Manufacturer Date | 2008-05-01 |
| Date Added to Maude | 2011-02-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LISA BARTAKOVICS |
| Manufacturer Street | 675 HEATHROW DR |
| Manufacturer City | LINCOLNSHIRE IL 60069 |
| Manufacturer Country | US |
| Manufacturer Postal | 60069 |
| Manufacturer Phone | 8474159763 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROGENY PREVA |
| Product Code | MUH |
| Date Received | 2010-08-13 |
| Model Number | PREVA |
| Catalog Number | P7017-P |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDMARK CORP |
| Manufacturer Address | 675 HEATHROW DR LINCOLNSHIRE IL 60069 US 60069 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-08-13 |