MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1998-03-11 for CHAIRMAN DENTAL CHAIR L1 007890 manufactured by Pelton & Crane, Llc.
[21247055]
It was reported by a dr's office that a dental hygienist was performing routine hygiene on a pt in a chairman dental chair when the chair's lift linkage broke causing the seat assembly along with the pt to fall down to the floor. There were no serious injuries reported. The pt received a scratch on her face. The hygienist received a small laceration on her hand. No medical treatment was required for either pt or hygienist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-1998-00005 |
| MDR Report Key | 155824 |
| Report Source | 08 |
| Date Received | 1998-03-11 |
| Date of Report | 1998-03-11 |
| Date Mfgr Received | 1998-02-16 |
| Device Manufacturer Date | 1974-08-01 |
| Date Added to Maude | 1998-03-16 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | RP |
| 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 | 1998-03-11 |
| Model Number | L1 |
| Catalog Number | 007890 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 151785 |
| Manufacturer | PELTON & CRANE, LLC |
| 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 | 1998-03-11 |