MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-17 for DEFEND DN-3000 manufactured by Mydent International.
[60687557]
Received notice from a dentist that after injecting the patient, the needle broke in patients mouth. The patient was then sent to a oral surgeon to have it removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2435126-2016-12345 |
| MDR Report Key | 6109609 |
| Date Received | 2016-11-17 |
| Date of Report | 2016-11-15 |
| Date of Event | 2016-10-27 |
| Device Manufacturer Date | 2015-10-10 |
| Date Added to Maude | 2016-11-17 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DEFEND |
| Generic Name | NEEDLE |
| Product Code | DZN |
| Date Received | 2016-11-17 |
| Model Number | DN-3000 |
| Catalog Number | DN-3000 |
| Lot Number | 8H120412 |
| Device Expiration Date | 2017-04-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MYDENT INTERNATIONAL |
| Manufacturer Address | 80 SUFFOLK COURT HAUPPAUGE NY 11788 US 11788 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-17 |