MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-22 for VISTA DENTAL PRODUCTS / SYRINGE SODIUM HYPOCHLORITE REF 502300 manufactured by Inter - Med, Inc..
[146199782]
Vista dental products - sodium hypochlorite syringe; upon preparing to irrigate during a root canal, it was discovered that the syringe when tested prior to irrigating, spilled a yellowish fluid followed by black fluid. Black fluid was expelled when testing other syringes. This was seen once previously but the staff thought it was a fluke and didn't see it again until (b)(6) 2019. Vista dental products, (b)(6) us. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086860 |
| MDR Report Key | 8636605 |
| Date Received | 2019-05-22 |
| Date of Report | 2019-05-17 |
| Date of Event | 2019-05-08 |
| Date Added to Maude | 2019-05-23 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VISTA DENTAL PRODUCTS / SYRINGE SODIUM HYPOCHLORITE |
| Generic Name | CLEANSER, ROOT CANAL |
| Product Code | KJJ |
| Date Received | 2019-05-22 |
| Catalog Number | REF 502300 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTER - MED, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-22 |