MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-04-13 for ULTRA SAFETY PLUS XL (27 GAUGE LONG) manufactured by Septodont Sas.
[20649111]
(b)(4). Initial information received on (b)(6) 2012. The dentist reported that a patient (unspecified gender), with no specific medical history, had been treated with ultra safety plus xl 27g long 0. 40x35mm sterile injectable system with protective sheath and handle. On an unspecified date, the patient experienced device failure. The device separated. The cannula stayed in the patient's mouth and was removed by surgery. According to the dentist, the cannula did not break; it became disconnected from the hub. The patient had fully recovered on an unspecified date. No other information is available. This case report is considered serious.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610964-2012-00001 |
| MDR Report Key | 2542535 |
| Report Source | 05 |
| Date Received | 2012-04-13 |
| Date of Report | 2012-03-27 |
| Date Mfgr Received | 2012-03-27 |
| Date Added to Maude | 2012-04-23 |
| 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 Street | 416 S. TAYLOR AVE. |
| Manufacturer City | LOUISVILLE CO 80027 |
| Manufacturer Country | US |
| Manufacturer Postal | 80027 |
| Manufacturer Phone | 8003835158 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRA SAFETY PLUS XL (27 GAUGE LONG) |
| Generic Name | CARTRIDGE SYRINGE |
| Product Code | EJI |
| Date Received | 2012-04-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEPTODONT SAS |
| Manufacturer Address | SAINT MAUR DES FOSSES 94100 FR 94100 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-04-13 |