MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-17 for D-LISH HOLIDAY PASTE 295011 manufactured by Young Dental Manufacturing Co 1, Llc..
[38414589]
Not a device problem.
Patient Sequence No: 1, Text Type: N, H10
[38414590]
Patient had an allergic reaction after using the paste - anaphylactic shock.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1941138-2016-00005 |
| MDR Report Key | 5442749 |
| Date Received | 2016-02-17 |
| Date of Report | 2016-01-21 |
| Date of Event | 2015-01-20 |
| Date Mfgr Received | 2015-01-20 |
| Date Added to Maude | 2016-02-17 |
| 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SARAH MOORE |
| Manufacturer Street | 13705 SHORELINE CT. E. |
| Manufacturer City | EARTH CITY MO 63045 |
| Manufacturer Country | US |
| Manufacturer Postal | 63045 |
| Manufacturer Phone | 3143440010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | D-LISH HOLIDAY PASTE |
| Generic Name | PROPHY PASTE |
| Product Code | EJR |
| Date Received | 2016-02-17 |
| Model Number | 295011 |
| Catalog Number | 295011 |
| Operator | DENTAL HYGIENIST |
| 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 CT. E. EARTH CITY MO 63045 US 63045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2016-02-17 |