MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-01-18 for ZOOBY 603210 manufactured by Young Dental Manufacturing I, Llc.
[133937654]
On 01/11/2019, young dental customer service was contacted by the mother of a child to report the following occurrence: a (b)(6) girl named (b)(6) had an allergic reaction after she had her teeth cleaned yesterday (b)(6) 2019. Child experienced a scratchy throat and her throat was closing up. She was given "benedryl". The product used on her was our zooby happy hippo cake. The mother of the child was not able to provide the grit. Child is allergic to peanuts, tree nuts, and fish. Customer service explained that peanuts, tree nuts, and fish are not present in our zooby happy hippo cake. The mother did say that the child might have had an allergic reaction from another place they visited yesterday. Place unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1941138-2019-00001 |
| MDR Report Key | 8261535 |
| Report Source | CONSUMER |
| Date Received | 2019-01-18 |
| Date of Report | 2019-01-17 |
| Date of Event | 2019-01-10 |
| Date Mfgr Received | 2019-01-11 |
| Date Added to Maude | 2019-01-18 |
| 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 | 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 | 0 |
| Brand Name | ZOOBY |
| Generic Name | PROPHYLAXIS PASTE |
| Product Code | EJR |
| Date Received | 2019-01-18 |
| Model Number | 603210 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | YOUNG DENTAL MANUFACTURING I, LLC |
| Manufacturer Address | 13705 SHORELINE COURT EAST EARTH CITY MO 63045 US 63045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2019-01-18 |