MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-02 for MIDMARK 029-4739-00 153829 manufactured by Midmark Corporation.
[66660096]
At the time of the report, an investigation could not be completed due to not having the device available to investigate.
Patient Sequence No: 1, Text Type: N, H10
[66660097]
A monitor fell from a midmark dental light mount into an empty chair next to a patient. No injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1523530-2017-00001 |
| MDR Report Key | 6296996 |
| Date Received | 2017-02-02 |
| Date of Report | 2017-02-02 |
| Date of Event | 2017-01-04 |
| Date Mfgr Received | 2017-01-04 |
| Device Manufacturer Date | 2013-06-10 |
| Date Added to Maude | 2017-02-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ADAM CLUTTER |
| Manufacturer Street | 60 VISTA DR. |
| Manufacturer City | VERSAILLES OH 45380 |
| Manufacturer Country | US |
| Manufacturer Postal | 45380 |
| Manufacturer Phone | 9375268474 |
| Manufacturer G1 | MIDMARK CORPORATION |
| Manufacturer Street | 60 VISTA DR. |
| Manufacturer City | VERSAILLES OH 45380 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45380 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MIDMARK |
| Generic Name | TRACK LIGHT MONITOR MOUNT |
| Product Code | EAZ |
| Date Received | 2017-02-02 |
| Model Number | 029-4739-00 |
| Catalog Number | 153829 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDMARK CORPORATION |
| Manufacturer Address | 60 VISTA DR. VERSAILLES OH 45380 US 45380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-02 |