MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2011-10-25 for CHAIRMAN CHAIR L1 007890 manufactured by Pelton & Crane.
[20793663]
It was reported from a third party claim that a pt was sitting in a pelton & crane chairman dental chair when allegedly the dental chair lowered and trapped the pt's legs causing serious, continuous, and permanent bodily injuries.
Patient Sequence No: 1, Text Type: D, B5
[20907137]
Pelton & crane received a third party claim which was very vague regarding the details of what actually happened to the pt and what the pt and operator were doing at the time of the alleged event. Pelton & crane has not been able to obtain any specific details regarding this third party claim other than the chair serial number. The dental chair was mfg over 30 years ago as it was mfg in april 1981.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017522-2011-00041 |
| MDR Report Key | 2310251 |
| Report Source | 00,01 |
| Date Received | 2011-10-25 |
| Date of Report | 2011-09-26 |
| Date of Event | 2010-04-14 |
| Date Mfgr Received | 2011-09-26 |
| Device Manufacturer Date | 1981-04-01 |
| Date Added to Maude | 2011-10-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | FRANK RAY, MGR. |
| Manufacturer Street | 11727 FRUEHAUF DR. |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal | 28273 |
| Manufacturer Phone | 7045877227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHAIRMAN CHAIR |
| Generic Name | DENTAL CHAIR |
| Product Code | KLC |
| Date Received | 2011-10-25 |
| Model Number | L1 |
| Catalog Number | 007890 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PELTON & CRANE |
| Manufacturer Address | 11727 FRUEHAUF DR. CHARLOTTE NC 28273 US 28273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-10-25 |