MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07,08 report with the FDA on 2009-02-19 for COMPUDENT STA STA-5110 NA manufactured by Milestone Scientific, Inc..
[1083311]
A compudent-sta unit was used in conjunction with a wand-sta handpiece to perform a dental anesthetic injection. The dentist performing the injection reported that necrosis of tissue occurred at the injection site. The dentist injected into a lower molar approximately. 9ml of 4% articane with a 1:100,000 concentration of epinephrine. The dosage and epinephrine concentrations administered by the dentist is specifically not recommended for these types of injections in the operators manual.
Patient Sequence No: 1, Text Type: D, B5
[8258016]
I have attached a report from dr, director of from the compudent-sta operators manual. In dr's report, he outlines his contacts with the dentist and his conclusions. The dentist stated to dr that she did not read the instructions in the manual. An initial evaluation was conducted of the unit involved in this event. The results of this evaluation showed that the unit was operating per specification. A more detailed analysis of the unit is underway.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004082685-2009-00001 |
| MDR Report Key | 1340099 |
| Report Source | 05,07,08 |
| Date Received | 2009-02-19 |
| Date of Report | 2009-02-18 |
| Date Mfgr Received | 2009-02-17 |
| Device Manufacturer Date | 2007-07-01 |
| Date Added to Maude | 2009-03-17 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEPHEN SOLOMON |
| Manufacturer Street | 220 SOUTH ORANGE AVE. |
| Manufacturer City | LIVINGSTON NJ 07039 |
| Manufacturer Country | US |
| Manufacturer Postal | 07039 |
| Manufacturer Phone | 9735352717 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPUDENT STA |
| Product Code | EJI |
| Date Received | 2009-02-19 |
| Returned To Mfg | 2009-02-17 |
| Model Number | STA-5110 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MILESTONE SCIENTIFIC, INC. |
| Manufacturer Address | 220 S. ORANGE AVE. LIVINGSTON NJ 07039 US 07039 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-02-19 |