MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-03 for DENTAL CHAIR manufactured by Aseptico.
[104422551]
While pt was siting in dental chair the dental chair broke, and the pt fell. Myself, other staff and 2 other spectators went to her aid to help her up off of the floor. At that time the pt stated that she was having lower back pain. Later that afternoon i called pt to check on her to see how she was doing and pt was in a lot of pain. Her children were there at the time trying to make her seek medical attention. Pt took pain meds and put on pain cream but nothing would stop the pain. I plan to do a f/u call tomorrow to check on the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076279 |
| MDR Report Key | 7395277 |
| Date Received | 2018-04-03 |
| Date of Report | 2018-03-30 |
| Date of Event | 2018-03-29 |
| Date Added to Maude | 2018-04-04 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DENTAL CHAIR |
| Generic Name | DENTAL CHAIR |
| Product Code | NRU |
| Date Received | 2018-04-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASEPTICO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-03 |