MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-28 for MIDMARK 18000 manufactured by Midmark Corportation.
[63811996]
The initial event was reviewed by a party of subject matter experts including quality engineering, post market surveillance and clinical affairs and determined to be not reportable. The health hazard evaluation board met to discuss the event on 11/29/2016 and determined with further consideration that the existing risk is to be further evaluated and increased to a level requiring reporting. This explains the initial appearance of late reporting. It can be noted however that the 30 day reporting requirement has been met based upon the final decision date of 11/29/2016.
Patient Sequence No: 1, Text Type: N, H10
[63811997]
Pediatrician contacted distributer from patterson dental with concerns that the 18000 dental chair may present a hazard for small children. If the pediatric patient wedges their legs between the arm rest and the provider while the chair is raised the leg may orient to a position that could result in injury. This is reported as concern; no injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1523530-2016-00006 |
| MDR Report Key | 6210796 |
| Date Received | 2016-12-28 |
| Date of Report | 2016-12-28 |
| Date of Event | 2016-11-07 |
| Date Added to Maude | 2016-12-28 |
| 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 | JANE CARROLL |
| Manufacturer Street | 60 VISTA DR. |
| Manufacturer City | VERSAILLES OH 45380 |
| Manufacturer Country | US |
| Manufacturer Postal | 45380 |
| Manufacturer Phone | 9372861111 |
| 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 | DENTAL CHAIR |
| Product Code | NRU |
| Date Received | 2016-12-28 |
| Model Number | 18000 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDMARK CORPORTATION |
| Manufacturer Address | 60 VISTA DR. VERSAILLES OH 45380 US 45380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-28 |