MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-07-17 for CHAIRMAN DENTAL CHAIR L1 007890 manufactured by Siemens Pelton & Crane.
[80935]
Through litigation activity, pelton & crane became aware of an incident involving a 10 year old original chairman dental chair. Based on info provided, it appears that a pt (a petite young lady) was exiting the chair after a dental procedure and slid her leg under the arm rest of the chair instead of the doctor rotating the arm rest away from the chair before the pt exited. Her foot then hit and activated the down switch on the base of the chair which lead to the chair's arm rest lowering down on the middle area of the thigh. At this time, no other info is being provided other than the pt bringing a lawsuit against the docotr based on alleged injuries sustained during the incident to her knee.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-1997-00099 |
| MDR Report Key | 106430 |
| Report Source | 05 |
| Date Received | 1997-07-17 |
| Date of Report | 1997-07-17 |
| Date of Event | 1995-06-08 |
| Device Manufacturer Date | 1986-11-01 |
| Date Added to Maude | 1997-07-22 |
| 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 | 0 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHAIRMAN DENTAL CHAIR |
| Generic Name | DENTAL OPERATORY CHAIR |
| Product Code | KLC |
| Date Received | 1997-07-17 |
| Model Number | L1 |
| Catalog Number | 007890 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 104627 |
| Manufacturer | SIEMENS PELTON & CRANE |
| Manufacturer Address | PO BOX 7800 CHARLOTTE NC 282417800 US |
| Baseline Brand Name | CHAIRMAN |
| Baseline Generic Name | DENTAL CHAIR |
| Baseline Model No | L1 |
| Baseline Catalog No | 007890 |
| Baseline ID | NA |
| Baseline Device Family | DENTAL OPERATORY WITH ACCESSORIES |
| Baseline Shelf Life Contained | A |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 1997-07-17 |