MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-07-16 for MIDMARK 153810 manufactured by Midmark Corp..
[4608291]
A dentist reported that a parent was seated sideways on the chair with child, who was the pt, on his lap when the midmark elevance dental chair was commended to move. The parent's leg was pinched in the gap between the chair seat and the back. No medical intervention was required.
Patient Sequence No: 1, Text Type: D, B5
[11979201]
An eval of the chair was done on-site and a review was conducted at our facility of a comparable lot. The chair design was reviewed for compliance to applicable safety standards and was found to be in compliance. The risk management file was reviewed and found to have issue to be evaluated. The failure that occurred has been determined to be related to failure to follow user manual guidance.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1523530-2014-00012 |
| MDR Report Key | 3952023 |
| Report Source | 07 |
| Date Received | 2014-07-16 |
| Date of Report | 2014-07-15 |
| Date of Event | 2014-06-16 |
| Date Mfgr Received | 2014-06-17 |
| Device Manufacturer Date | 2014-03-01 |
| Date Added to Maude | 2014-07-24 |
| 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 | CRAIG RAMMEL |
| Manufacturer Street | 60 VISTA DR. |
| Manufacturer City | VERSAILLES OH 45380 |
| Manufacturer Country | US |
| Manufacturer Postal | 45380 |
| Manufacturer Phone | 9375263662 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIDMARK |
| Generic Name | ELEVANCE DENTAL CHAIR |
| Product Code | NRU |
| Date Received | 2014-07-16 |
| Model Number | 153810 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDMARK CORP. |
| Manufacturer Address | 60 VISTA DR. VERSAILLES OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-16 |