MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2009-12-17 for PROGENY PREVA P7017P manufactured by Midmark Corporation.
[20925902]
A service technician from the distributor reported that the mechanical structure of a preva intraoral unit, (b) (4), separated from its wall mount at dr. (b) (6) dental office. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[21200264]
Conclusions: improper installation: the pilot holes were oversized, which prevented the wall mount lag screws from getting sufficient grip in the wood studs. The pilot hole size is specified in the installation manual.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423380-2009-00027 |
| MDR Report Key | 1575525 |
| Report Source | 08 |
| Date Received | 2009-12-17 |
| Date of Report | 2009-12-16 |
| Date of Event | 2009-11-20 |
| Date Mfgr Received | 2009-11-20 |
| Device Manufacturer Date | 2007-05-01 |
| Date Added to Maude | 2010-07-12 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 8474159800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROGENY PREVA |
| Product Code | MUH |
| Date Received | 2009-12-17 |
| Model Number | PREVA |
| Catalog Number | P7017P |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2009-12-17 |