MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 1997-09-26 for CHAIRMAN DENTAL CHAIR L1 007890 manufactured by Siemens Pelton & Crane.
[112785]
Dental chair broke. The dr. Said that he was inclining a patient up in the chair for an x-ray when the lift linkage in the chair broke causing the patient to fall and hit their head on the rear counter top. The patient received a sore neck and a headache. The chair back with the patient also fell on the dental assistant's leg causing her to get a contusion on her leg. The dr. Said that there were no permanent injuries to neither the patient nor the dental assistant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-1997-00122 |
| MDR Report Key | 123965 |
| Report Source | 01,05 |
| Date Received | 1997-09-26 |
| Date of Report | 1997-09-26 |
| Date Mfgr Received | 1997-08-29 |
| Device Manufacturer Date | 1975-03-01 |
| Date Added to Maude | 1997-10-03 |
| 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 |
| Remedial Action | RL |
| 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 | 1997-09-26 |
| Model Number | L1 |
| Catalog Number | 007890 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 121377 |
| 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 | 1997-09-26 |