MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07,08 report with the FDA on 2006-12-12 for PREMIER BIG EASY ULTRALITE GRACEY 11/12 * 05611 manufactured by Premier Dental Products Co..
[553466]
The rdh was scaling the #18 tooth (2nd molar) on the lingual side of the patient's mouth with a big easy ultralite gracey 11/12 curette when the instrument tip broke and the patient swallowed the tip. The patient went to the emergency room where the emergency room dr used an endoscope to successfully remove the 5-6mm piece from the patient's stomach. The office reported the patient was doing fine in a follow up conversation. As of today, premier has been unable to get the instrument back for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2511556-2006-00001 |
| MDR Report Key | 793382 |
| Report Source | 05,07,08 |
| Date Received | 2006-12-12 |
| Date of Report | 2006-11-09 |
| Date of Event | 2006-11-09 |
| Date Mfgr Received | 2006-11-09 |
| Date Added to Maude | 2006-12-14 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | VINCENT D'ALESSANDRO |
| Manufacturer Street | 1710 ROMANO DR |
| Manufacturer City | PLYMOUTH MEETING PA 19462 |
| Manufacturer Country | US |
| Manufacturer Postal | 19462 |
| Manufacturer Phone | 6102396015 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREMIER BIG EASY ULTRALITE GRACEY 11/12 |
| Generic Name | ELA |
| Product Code | ELA |
| Date Received | 2006-12-12 |
| Model Number | * |
| Catalog Number | 05611 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 781001 |
| Manufacturer | PREMIER DENTAL PRODUCTS CO. |
| Manufacturer Address | * PLYMOUTH MEETING PA 19462 US |
| Baseline Brand Name | PREMIER BIG EASY ULTRALITE GRACEY 11/12 |
| Baseline Generic Name | ELA |
| Baseline Model No | * |
| Baseline Catalog No | 05611 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-12-12 |