MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-01-22 for PROGENY JB-70 I7017 manufactured by Midmark Corporation.
[1447346]
A dealer service engineer reported that the jb-70 intraoral unit, (b) (4), would expose on its own at dr (b) (6) dental office.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423380-2009-00030 |
| MDR Report Key | 1593428 |
| Report Source | 08 |
| Date Received | 2010-01-22 |
| Date of Report | 2010-01-11 |
| Date of Event | 2009-12-17 |
| Date Mfgr Received | 2009-12-17 |
| Device Manufacturer Date | 2004-10-01 |
| 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 JB-70 |
| Product Code | MUH |
| Date Received | 2010-01-22 |
| Model Number | JB-70 |
| Catalog Number | I7017 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2010-01-22 |