MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-05-20 for EXPLORER DE #5 * 100-8008 manufactured by Shanghai Dental Instrument Factory.
[355201]
Notification received in 2004 of an explorer tip breaking off and being swallowed by a pt in 2004. Subsequent x-rays showed the tip to be located in the duodenum. Pt underwent surgery wherein the tip was removed via scope. Incident occurred at 8 am. Pt was sent home from hospital at 4:30pm. Pt is now fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411236-2004-11616 |
| MDR Report Key | 525969 |
| Date Received | 2004-05-20 |
| Date of Report | 2004-05-20 |
| Date of Event | 2004-05-05 |
| Date Facility Aware | 2004-05-20 |
| Report Date | 2004-05-20 |
| Date Reported to FDA | 2004-05-20 |
| Date Added to Maude | 2004-05-24 |
| 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 DE #5 |
| Generic Name | DENTAL INSTRUMENT |
| Product Code | EKB |
| Date Received | 2004-05-20 |
| Model Number | * |
| Catalog Number | 100-8008 |
| Lot Number | 1103 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 515107 |
| Manufacturer | SHANGHAI DENTAL INSTRUMENT FACTORY |
| Manufacturer Address | 820 LING SHI RD SHANGHAI CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2004-05-20 |