MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-13 for RIVA STAR SILVER DIAMINE FLUORIDE manufactured by Sdi Limited.
[136862433]
Product was riva star silver diamine fluoride. Immediately upon placement on tooth to arrest decay on a primary molar, inflammation and a chemical burn occurred. Shortly after placement there was redness at the gumline and on the vermillion border of the lip. Shortly hereafter there was some tissue slough at the gumline and a brown to black spot occurred on the lip. While gauze and cotton rolls had been used for isolation it was not adequate. Note: device 510(k) : k172047.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084053 |
| MDR Report Key | 8339473 |
| Date Received | 2019-02-13 |
| Date of Report | 2019-02-05 |
| Date of Event | 2019-01-30 |
| Date Added to Maude | 2019-02-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | RIVA STAR SILVER DIAMINE FLUORIDE |
| Generic Name | CAVITY VARNISH |
| Product Code | LBH |
| Date Received | 2019-02-13 |
| Returned To Mfg | 2019-02-04 |
| Lot Number | 11272371 |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SDI LIMITED |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-13 |