MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-11-18 for EXPLORER SE #23 * 100 3620 manufactured by Shanghai Dental Instrument Factory.
[297647]
Tip of explorer broke off during a dental procedure. Pt swallowed tip-went to e. R. For x-rays.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411236-2003-10504 |
| MDR Report Key | 496466 |
| Date Received | 2003-11-18 |
| Date of Report | 2003-11-17 |
| Date of Event | 2003-11-13 |
| Date Facility Aware | 2003-11-13 |
| Report Date | 2003-11-17 |
| Date Reported to FDA | 2003-11-18 |
| Date Reported to Mfgr | 2003-11-18 |
| Date Added to Maude | 2003-11-21 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXPLORER SE #23 |
| Generic Name | DENTAL INSTRUMENT |
| Product Code | EKB |
| Date Received | 2003-11-18 |
| Model Number | * |
| Catalog Number | 100 3620 |
| Lot Number | 0103 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 485200 |
| Manufacturer | SHANGHAI DENTAL INSTRUMENT FACTORY |
| Manufacturer Address | NO. 820 LINGSHI RD. SHANGHAI CH 200072 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-11-18 |