MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2006-04-07 for COACHMAN II DENTAL CHAIR L6 3006801 manufactured by Pelton & Crane.
[456266]
A mother and her three children were all in a dental operatory at the same time while the oldest child, was having his teeth cleaned. When the dental hygienist was finished cleaning the child's teeth she hit the exit button to position the chair to let the child out, however, she did not realize that the youngest child had crawled up under the chair. The chair went down onto the child's head and face. The child started to scream so the dental hygienist stopped the chair and raised it back up. The mother grabbed the child by the feet and pulled the child out. The child received severe lacerations to the facial area and some bleeding to the back of his head. The child was sent immediately to a hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2006-00002 |
| MDR Report Key | 699090 |
| Report Source | 00 |
| Date Received | 2006-04-07 |
| Date of Report | 2006-04-07 |
| Date of Event | 2006-01-10 |
| Date Mfgr Received | 2006-03-17 |
| Device Manufacturer Date | 1992-09-01 |
| Date Added to Maude | 2006-04-14 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Street | 11727 FRUEHAUF DR |
| 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 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COACHMAN II DENTAL CHAIR |
| Generic Name | DENTAL CHAIR |
| Product Code | NRU |
| Date Received | 2006-04-07 |
| Model Number | L6 |
| Catalog Number | 3006801 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 688178 |
| Manufacturer | PELTON & CRANE |
| Manufacturer Address | 11727 FRUEHAUF DR. CHARLOTTE NC 28273 US |
| Baseline Brand Name | COAHMAN II DENTAL CHAIR |
| Baseline Generic Name | DENTAL CHAIR |
| Baseline Model No | L6 |
| Baseline Catalog No | 3006801, 3006827 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2006-04-07 |