MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-01-20 for SPIRIT 3000 CHAIR SP30 3003 manufactured by Pelton & Crane.
[439646]
Dentist was performing a medical procedure when the dental chair allegedly moved on its own causing the dentist to cut the inside of the patient's mouth. The doctor said the pt had to get one to two stitches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2005-00028 |
| MDR Report Key | 666619 |
| Report Source | 05,06 |
| Date Received | 2006-01-20 |
| Date of Report | 2006-01-13 |
| Date of Event | 2005-12-16 |
| Date Mfgr Received | 2005-12-16 |
| Device Manufacturer Date | 2005-05-01 |
| Date Added to Maude | 2006-01-25 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 11727 FRUEHAUF DRIVE |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal | 28273 |
| Manufacturer Phone | 7045877227 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPIRIT 3000 CHAIR |
| Generic Name | DENTAL CHAIR |
| Product Code | KLC |
| Date Received | 2006-01-20 |
| Returned To Mfg | 2005-12-22 |
| Model Number | SP30 |
| Catalog Number | 3003 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 656001 |
| Manufacturer | PELTON & CRANE |
| Manufacturer Address | 11727 FRUEHAUF DR. CHARLOTTE NC 28273 US |
| Baseline Brand Name | SPIRIT 3000 CHAIR |
| Baseline Generic Name | DENTAL CHAIR |
| Baseline Model No | SP30 |
| Baseline Catalog No | 3003 |
| Baseline ID | NA |
| Baseline Device Family | DENTAL CHAIRS |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-01-20 |