MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-08-07 for D-LISH ASSORTED FLAVORS MEDIUM 304120 manufactured by Young Dental.
[81966346]
A dental hygienist used dlish paste on a patient. The patient suffered anaphylactic shock approximately 20 minutes after the appointment on wednesday (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1941138-2017-00004 |
| MDR Report Key | 6771738 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-08-07 |
| Date of Report | 2017-08-07 |
| Date of Event | 2017-07-26 |
| Date Mfgr Received | 2017-07-28 |
| Device Manufacturer Date | 2016-06-30 |
| Date Added to Maude | 2017-08-07 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOSE ESPINO |
| Manufacturer Street | 13705 SHORELINE COURT EAST |
| 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 | 3 |
| Brand Name | D-LISH ASSORTED FLAVORS MEDIUM |
| Generic Name | PROPHYLAXIS PASTE |
| Product Code | EJR |
| Date Received | 2017-08-07 |
| Model Number | 304120 |
| Catalog Number | 304120 |
| Lot Number | 29848 |
| Device Expiration Date | 2018-06-30 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | YOUNG DENTAL |
| Manufacturer Address | 13705 SHORELLINE COURT EAST EARTH CITY MO 63045 US 63045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-07 |