MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2011-01-31 for COMPUDENT STA STA-5220 manufactured by Milestone Scientific.
[19938635]
(b)(6), a practicing dentist in the (b)(6) made a complaint regarding two of his pts who had adverse tissue reactions after p-asa injections with the sta (single tooth anesthesia) instrument. The pts complained of post-operative discomfort and minor tissue ulceration at the site of the injections; all conditions have been resolved with no permanent tissue damage. Adverse tissue reactions associated with the p-asa injection have been very rarely reported over the last twelve years, and the cause of the post-operative complication in question should not be attributed to the sta, but to one or a combination of the following causative factors. Excessive volume of anesthetic delivered, especially with 4% drugs; excessive flow rate of anesthetic delivered; excessive concentration of epinephrine delivered; an error in injection technique, such as an injection directly into the naso-palatine papilla or tissue rather than into the naso-palatine canal; the anesthetic caused an untoward iatrogenic reaction for reasons that cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[20088150]
A compudent-sta unit was used in conjunction with a wand-sta handpiece to perform a dental anesthetic injection. The dentist reported that palatal infiltrations resulted in ulceration to the palate between the upper teeth and incisive papilla. The case was in an active smoker or recently stopped smoker. The case resolved spontaneously.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004082685-2011-00003 |
| MDR Report Key | 1998668 |
| Report Source | 05,08 |
| Date Received | 2011-01-31 |
| Date of Report | 2011-01-26 |
| Date of Event | 2010-10-08 |
| Date Mfgr Received | 2011-01-03 |
| Date Added to Maude | 2011-02-25 |
| 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 |
| Manufacturer G1 | TRICOR SYSTEMS |
| Manufacturer Street | 1650 TODD FARM DR. |
| Manufacturer City | ELGIN IL 60123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60123 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPUDENT STA |
| Product Code | EJI |
| Date Received | 2011-01-31 |
| Model Number | STA-5220 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MILESTONE SCIENTIFIC |
| Manufacturer Address | 220 SOUTH ORANGE AVE. LIVINGSTON NJ 07039 US 07039 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-01-31 |