MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-03-08 for THE WAND PS-0021 NA manufactured by Milestone Scientific, Inc..
[145454]
A dentist uses the wand, a computer-controlled local anesthetic delivery system. Recent re-orders of the handpiece are labeled as "wand plus" indicating the handpiece is new, improved or different from previous shipments. The handpiece is the holder for the cartridge that contains the novocaine. The problem reported involves the use of monoject needles. Instructions for use for monoject needles are to "twist to resist". Dentist reported that if the operator does not twist tightly enough to form a seal, it is possible to inject air. Dentist has had to abort procedures due to this problem. Called milestone scientific who did agree that there was a problem with their instructions. No injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4002716 |
| MDR Report Key | 269106 |
| Date Received | 2000-03-08 |
| Date of Report | 2000-03-02 |
| Date Added to Maude | 2000-03-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THE WAND |
| Generic Name | ANESTHETIC DELIVERY SYSTEM FOR DENTAL PROCEDURES |
| Product Code | EJI |
| Date Received | 2000-03-08 |
| Model Number | PS-0021 |
| Catalog Number | NA |
| Lot Number | NI |
| ID Number | 50 WANDS PER BOX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 260523 |
| Manufacturer | MILESTONE SCIENTIFIC, INC. |
| Manufacturer Address | 151 SOUTH PFINGSTEN RD UNIT T DEERFIELD IL 60015 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-03-08 |