MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-22 for SPARKLE FREE PROPHY PASTE UPSMF manufactured by E.c. Moore Company Inc..
[34164177]
The patient became sick after having a dental procedure that used sparkle free prophy paste. No medical treatment was sought. (b)(4) is not the manufacturer of sparkle free prophy pase, it is just the distributor. This complaint will continue to be monitored in the (b)(4) complaint system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2433773-2015-00004 |
| MDR Report Key | 5320090 |
| Date Received | 2015-12-22 |
| Date of Report | 2015-12-22 |
| Date of Event | 2015-11-23 |
| Report Date | 2015-12-22 |
| Date Reported to Mfgr | 2015-12-22 |
| Date Added to Maude | 2015-12-22 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 3 |
| Brand Name | SPARKLE FREE PROPHY PASTE |
| Generic Name | PROPHY PASTE |
| Product Code | EJR |
| Date Received | 2015-12-22 |
| Model Number | UPSMF |
| Operator | DENTAL HYGIENIST |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | E.C. MOORE COMPANY INC. |
| Manufacturer Address | 13325 LEONARD ST. DEARBORN MI 48126 US 48126 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-22 |