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 P7016 manufactured by Midmark Corporation.
[19459319]
A service tech from the distributor reported that the mechanical structure of a preva intraoral unit, (b) (4), separated from its wall mount at (b) (6) dental office. No injury reported.
Patient Sequence No: 1, Text Type: D, B5
[19714798]
Conclusion: improper installation: the 3" long lag screws used to attach the wall mount were too short due to the fact that there are 2 layers of sheetrock. The thick sheetrock prevented the lag screws from getting a good grip in the wood studs. The installation manual points out that "progeny provides fasteners for average installations. Based on specific installation condition, it may be necessary to choose an alternate fastener or fastening methods".
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423380-2009-00028 |
| MDR Report Key | 1575527 |
| Report Source | 08 |
| Date Received | 2009-12-17 |
| Date of Report | 2009-12-15 |
| Date of Event | 2009-11-25 |
| Date Mfgr Received | 2009-11-25 |
| Device Manufacturer Date | 2007-09-01 |
| 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 | P7016 |
| 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 |