MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-03-08 for D-LISH PROPHY PASTE WITH A D-LISH TASTE - GRAPE, FINE 303220 manufactured by Young Dental Manufacturing Co 1, Llc..
[39888743]
A dental student was using this product on a friend. There was no mention that this individual was performing this procedure under the supervision of a teacher. This product's directions for use state that it is to be administered professionally. Without the oversite of the medical professional it is hard to tell is there were any other factors that may have contributed to this adverse reaction. An allergen statement for the artificial grape flavoring used in this product was available, and states that the flavoring is free of the most common food allergens. Since the product was not returned for investigation (was used) and a lot number was not received, performing an analysis on this product is difficult. Therefore, the device history records for the past month were reviewed for any anomalies, none were found.
Patient Sequence No: 1, Text Type: N, H10
[39888744]
A dental student received d-lish grape fine paste from her school. She used it to polish one of her friend's teeth. Her friend had an allergic reaction. Her friend's lips swelled. She is not aware of any allergies other than avocado. Medical attention was not required. She took benadryl and the side effects subsided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1941138-2016-00009 |
| MDR Report Key | 5486155 |
| Report Source | OTHER |
| Date Received | 2016-03-08 |
| Date of Report | 2016-02-29 |
| Date of Event | 2016-02-26 |
| Date Mfgr Received | 2016-02-26 |
| Date Added to Maude | 2016-03-08 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. SARAH MOORE |
| Manufacturer Street | 13705 SHORELINE COURT E. |
| Manufacturer City | EARTH CITY MO 63045 |
| Manufacturer Country | US |
| Manufacturer Postal | 63045 |
| Manufacturer Phone | 3143440010 |
| Manufacturer G1 | YOUNG DENTAL MANUFACTURING CO 1, LLC |
| Manufacturer Street | 13705 SHORELINE COURT E. |
| Manufacturer City | EARTH CITY MO 63045 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63045 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | D-LISH PROPHY PASTE WITH A D-LISH TASTE - GRAPE, FINE |
| Generic Name | PROPHY PASTE |
| Product Code | EJR |
| Date Received | 2016-03-08 |
| Model Number | 303220 |
| Catalog Number | 303220 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | YOUNG DENTAL MANUFACTURING CO 1, LLC. |
| Manufacturer Address | 13705 SHORELINE COURT E. EARTH CITY MO 63045 US 63045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-03-08 |