MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-07-01 for COMPUDENT/WAND PLUS WA-2050-301 manufactured by Milestone Scientific.
[15900536]
A compudent instrument was used in conjunction with a wand handpiece to perform a dental anesthetic injection. The user installed the wand handpiece to the instrument and performed a successful inferior alveolar block injection. After delivering the first cartridge, the user removed the needle from the mandibular tissue, replaced the spent cartridge with a new one, then gave the second injection. Upon removing the handpiece from pt's mouth, the needle separated from the handpiece and lodged in the pt's buccalmucosa. The pt was taken to an oral surgeon, who discussed two alternative treatment plans with the pt. The surgeon could surgically remove the needle or leave the needle in place and observe the condition, with the option of removal at a later time if the needle created any problem. The pt opted to leave the needle in place for the time being and continue to monitor the situation. The pt was not experiencing any discomfort or other issue due to the embedded needle.
Patient Sequence No: 1, Text Type: D, B5
[16353302]
The handpiece was not returned to milestone for eval. Therefore, it is not possible to determine the actual failure mode. Info from the dentist's interview, a review of the product labeling and field return data was used in the analysis of this event. In this case the dentist used a handpiece with a 30 gauge 1 inch long needle attached. The product labeling recommends a handpiece with a 27 gauge 1 1/4 inch long needle attached for this type of injection. Without the actual handpiece, it cannot be determined if the use of the shorter, thinner needle contributed to this adverse event. However, the use of a shorter needle would make recovery of the needle more difficult. Note: the needle is not manufactured by milestone scientific. It is a purchased item.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004082685-2015-00001 |
| MDR Report Key | 4890761 |
| Report Source | 05,07 |
| Date Received | 2015-07-01 |
| Date of Report | 2015-06-30 |
| Date of Event | 2015-06-04 |
| Date Mfgr Received | 2015-06-04 |
| Date Added to Maude | 2015-07-07 |
| 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 | 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/WAND PLUS |
| Product Code | EJI |
| Date Received | 2015-07-01 |
| Model Number | WA-2050-301 |
| Lot Number | 140403 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MILESTONE SCIENTIFIC |
| Manufacturer Address | 220 S. ORANGE AVE LIVINGSTON NJ 07039 US 07039 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-01 |