MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-11-12 for PROGENY PREVA P7017-P manufactured by Midmark Corporation.
[1252912]
A progeny sales representative 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
[8304128]
Results: the root cause of this case is not clear. Based on the analysis from progeny design engineering, the possible root causes are: oversized pilot hole, stripped hole, or non-standard installation (drywall thickness exceed 3/8"). Conclusion: improper installation - the root cause of this case is not clear. Based on the analysis from progeny design engineering, the possible root causes are: oversized pilot hole, stripped hole, or non-standard installation (drywall thickness exceed 3/8"). The ul report of a standard progeny system mount (2 3/8" x 3" lag screws on 2/4 stud) demonstrates that a correctly installed x-ray unit can withstand 6 times the system weight.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423380-2009-00022 |
| MDR Report Key | 1545019 |
| Report Source | 07 |
| Date Received | 2009-11-12 |
| Date of Report | 2009-11-11 |
| Date of Event | 2009-10-14 |
| Date Mfgr Received | 2009-10-14 |
| Device Manufacturer Date | 2008-05-01 |
| Date Added to Maude | 2010-05-25 |
| 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 | 8474159800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROGENY PREVA |
| Product Code | MUH |
| Date Received | 2009-11-12 |
| Model Number | PREVA |
| Catalog Number | P7017-P |
| 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 | 2009-11-12 |