MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-06-11 for PROGENY PREVA P7016 manufactured by Midmark Corporation.
[1563498]
A service technician from dealer reported that the mechanical structure of a preva intra-oral x-ray unit, (b)(4), separated from the wall. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[8563083]
Results: the x-ray unit was mounted in a center island cabinet. The backing of the cabinet was not strong enough.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423380-2010-00015 |
| MDR Report Key | 1755365 |
| Report Source | 08 |
| Date Received | 2010-06-11 |
| Date of Report | 2010-06-11 |
| Date of Event | 2010-05-21 |
| Date Mfgr Received | 2010-05-21 |
| Device Manufacturer Date | 2010-02-01 |
| 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 | 2010-06-11 |
| Returned To Mfg | 2010-06-01 |
| Model Number | PREVA |
| Catalog Number | P7016 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDMARK CORPORATION |
| Manufacturer Address | 675 HEATHROW DRIVE LINCOLNSHIRE IL 60069 US 60069 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-11 |