MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2004-12-01 for EXPLORER SE #23 * 100-3620 manufactured by Shanghai Dental Instrument Factory.
[14873250]
In 2004 facility inc. Received notification via the patients representative that their client had swallowed the tip of an explorer that had broken during a dental examination. The tip was located by x-ray in the esophagus of the patient, and the patient was subsequently anesthetized and the tip removed. The patient has recovered well with no after effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411236-2004-12871 |
| MDR Report Key | 558149 |
| Report Source | 08 |
| Date Received | 2004-12-01 |
| Date of Report | 2004-11-22 |
| Date of Event | 2004-04-01 |
| Date Facility Aware | 2004-11-11 |
| Report Date | 2004-11-22 |
| Date Mfgr Received | 2004-11-11 |
| Device Manufacturer Date | 2003-01-01 |
| Date Added to Maude | 2004-12-08 |
| 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 | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 3232 NORTH ROCKWELL ST |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal | 60618 |
| Manufacturer Phone | 7739753975 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0832/0834-4 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXPLORER SE #23 |
| Generic Name | DENTAL INSTRUMENT |
| Product Code | EKB |
| Date Received | 2004-12-01 |
| Model Number | * |
| Catalog Number | 100-3620 |
| Lot Number | 0103 |
| 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 | 547809 |
| Manufacturer | SHANGHAI DENTAL INSTRUMENT FACTORY |
| Manufacturer Address | 820 LING SHI ROAD SHANGHAI CH |
| Baseline Brand Name | EXPLORER SE #23 |
| Baseline Generic Name | DENTAL INSTRUMENT |
| Baseline Model No | * |
| Baseline Catalog No | 100-3620 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2004-12-01 |