MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-12 for RECLINING DENTAL CHAIR manufactured by .
[17220927]
Spinal dislocation caused by excessive protruding non-adjustable padding of fully reclined dental chair for the entire duration of teeth-cleaning appointment. In reclined position, the huge lumbar "support" distorted my spine and caused joints to dislocate. Pain from dislocated back joints increased during the appointment and persisted afterwards. One day later, use of an inclined sit-up board enabled the back joints to shift back into proper position; this resolved the dislocation and pain caused by the fixed huge lumbar hump on the reclined dental chair.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5039678 |
MDR Report Key | 4352651 |
Date Received | 2014-12-12 |
Date of Report | 2014-12-12 |
Date of Event | 2013-01-14 |
Date Added to Maude | 2014-12-23 |
Event Key | 0 |
Report Source Code | Voluntary report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 0 |
Reporter Occupation | PATIENT |
Health Professional | 0 |
Initial Report to FDA | 3 |
Report to FDA | 0 |
Event Location | 0 |
Single Use | 0 |
Previous Use Code | 0 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | RECLINING DENTAL CHAIR |
Generic Name | RECLINING DENTAL CHAIR |
Product Code | KLC |
Date Received | 2014-12-12 |
Operator | HEALTH PROFESSIONAL |
Device Sequence No | 1 |
Device Event Key | 0 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2014-12-12 |