MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2010-12-21 for KNIGHT 152723 manufactured by Midmark Corp..
[1818233]
The upper portion of chair came apart with patient in chair. The chair top tipped allowing the patient to fall to the floor. The patient hit their head but no injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[8872735]
Photographs of the chair frame indicate that the welds holding the chair top to the base were broken. When the welds broke, the chair top pivoted allowing the patient to fall out of the chair.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1523530-2010-00017 |
| MDR Report Key | 1960143 |
| Report Source | 07,08 |
| Date Received | 2010-12-21 |
| Date of Report | 2010-12-16 |
| Date of Event | 2010-12-06 |
| Date Mfgr Received | 2010-12-10 |
| Device Manufacturer Date | 2009-10-01 |
| Date Added to Maude | 2011-02-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DONALD CARR |
| 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 | KNIGHT |
| Generic Name | CHAIR, DENTAL, WITHOUT OPERATIVE UNIT |
| Product Code | KLC |
| Date Received | 2010-12-21 |
| Model Number | 152723 |
| 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 CORP. |
| Manufacturer Address | VERSAILLES OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-21 |