MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-12-02 for SPIRIT 1500 DENTAL CHAIR SP15 manufactured by Pelton & Crane.
[2502980]
A dentist was performing routine dental treatment to the patient when the dentist left the room for an estimated 20 seconds when the dentist heard a scream coming from the dental operatory. When the dentist entered the room the dentist saw the patient had severed their left pinky finger from the last joint on the end of her finger. It was reported the severed tip of the patients finger was hanging on the rotational arm rest.
Patient Sequence No: 1, Text Type: D, B5
[9565748]
Pelton and crane received this complaint through an insurance company and is currently trying to schedule an evaluation of the chair. However an agreed upon time with the plaintiffs as well as the dentists attorneys has yet to be finalized.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017522-2011-00047 |
| MDR Report Key | 2362946 |
| Report Source | 00 |
| Date Received | 2011-12-02 |
| Date of Report | 2011-11-02 |
| Date of Event | 2011-10-08 |
| Date Mfgr Received | 2011-11-02 |
| Device Manufacturer Date | 2000-06-01 |
| Date Added to Maude | 2011-12-12 |
| 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, MANAGER |
| 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 | SPIRIT 1500 DENTAL CHAIR |
| Generic Name | DENTAL CHAIR |
| Product Code | KLC |
| Date Received | 2011-12-02 |
| Model Number | SP15 |
| Catalog Number | SP15 |
| 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. Deathisabilit | 2011-12-02 |