MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-14 for MIDMARK DENTAL TRACK LIGHT MONITOR 029-4857-00 153963 manufactured by Midmark Corporation.
[145112875]
At the time of this report, a physical investigation could not be completed due to the device being unavailable for evaluation. However, after reviewing pictures provided by the user facility it appears that a weld on the flex arm assembly broke causing the monitor to fall. The weld breaking is likely the result of a manufacturing defect, and a replacement flex arm assembly was sent to the user facility.
Patient Sequence No: 1, Text Type: N, H10
[145112876]
The user facility discovered the dental monitor hanging by the wires and the down tube that holds the monitor broken. No injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1523530-2019-00002 |
| MDR Report Key | 8607907 |
| Date Received | 2019-05-14 |
| Date of Report | 2019-05-13 |
| Date of Event | 2019-03-29 |
| Device Manufacturer Date | 2017-10-23 |
| Date Added to Maude | 2019-05-14 |
| 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 | MR. 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MIDMARK DENTAL TRACK LIGHT MONITOR |
| Generic Name | LIGHT, OPERATING, DENTAL |
| Product Code | EAZ |
| Date Received | 2019-05-14 |
| Model Number | 029-4857-00 |
| Catalog Number | 153963 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDMARK CORPORATION |
| Manufacturer Address | 60 VISTA DRIVE VERSAILLES OH 45380 US 45380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-14 |