MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-04-26 for SPARKLE FREE PROPHY PASTE UPSFMC manufactured by E.c. Moore Co..
[143385408]
A facility reported that a patient experienced an allergic reaction after a routine dental cleaning using sparkle free prophy paste. Crosstex followed up with the facility for more information. It was reported the patient experienced symptoms of redness and a rash around her mouth. It was reported that the symptoms lasted for more than two weeks and she is currently under medical supervision. Crosstex confirmed with the manufacturer of sparkle free prophy paste, e. C. Moore co. , that there have been no changes to the formula or production procedures. The sparkle free prophy paste safety data sheet (sds) states that this product may cause skin irritation. This complaint will continue to be monitored in the crosstex complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[143385409]
A facility reported that a patient experienced an allergic reaction after a routine dental cleaning using sparkle free prophy paste.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2433773-2019-00002 |
| MDR Report Key | 8557045 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-04-26 |
| Date of Report | 2019-04-26 |
| Date of Event | 2019-03-27 |
| Date Mfgr Received | 2019-03-27 |
| Date Added to Maude | 2019-04-26 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | HANNAH SHRADER |
| Manufacturer Street | 10 RANICK ROAD |
| Manufacturer City | HAUPPAUGE NY 11788 |
| Manufacturer Country | US |
| Manufacturer Postal | 11788 |
| Manufacturer Phone | 7635596863 |
| Manufacturer G1 | E.C MOORE CO. |
| Manufacturer Street | 13325 LEONARD ST |
| Manufacturer City | DEARBORN MI 48126 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 48126 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPARKLE FREE PROPHY PASTE |
| Generic Name | PROPHYLAXIS PASTE |
| Product Code | EJR |
| Date Received | 2019-04-26 |
| Model Number | UPSFMC |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | E.C. MOORE CO. |
| Manufacturer Address | 13325 LEONARD ST DEARBORN MI 48126 US 48126 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-26 |