MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-08-22 for PROGENY VANTAGE 60-A0001 V5000 manufactured by Midmark Corporation.
[4828414]
A dentist reported to dealer who then reported to midmark that the column of a vantage x-ray unit, serial number (b)(4), continued moving up or down after the movement control button was released. The dental office reported to the midmard representative that the unit has been having this issue for a while and has gotten worse lately. The midmark representative called the dental office and confirmed that there was no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423380-2014-00005 |
| MDR Report Key | 4084944 |
| Report Source | 08 |
| Date Received | 2014-08-22 |
| Date of Report | 2014-08-20 |
| Date of Event | 2014-07-23 |
| Date Mfgr Received | 2014-07-23 |
| Device Manufacturer Date | 2010-10-01 |
| Date Added to Maude | 2014-09-17 |
| 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 | PENG LIN |
| Manufacturer Street | 675 HEATHROW DR. |
| Manufacturer City | LINCOLNSHIRE IL 60065 |
| Manufacturer Country | US |
| Manufacturer Postal | 60065 |
| Manufacturer Phone | 8474159787 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROGENY VANTAGE |
| Generic Name | SYSTEM, X-RAY, EXTRAORAL SOURCE, DIGITAL |
| Product Code | MUH |
| Date Received | 2014-08-22 |
| Model Number | 60-A0001 |
| Catalog Number | V5000 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDMARK CORPORATION |
| Manufacturer Address | 675 HEATHROW DR. LINCOLNSHIRE IL 60069 US 60069 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-22 |