MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-03-08 for ZOOBY PROPHY PASTE - HAPPY HIPPO CAKE, MEDIUM 603110 manufactured by Young Dental Manufacturing Co 1, Llc.
[39928703]
Since the product was not able to be received back for analysis, a review of the device history records for zooby prophy paste - happy hippo cake, medium lot #13241 was conducted. No anomalies were observed on the device history records to indicate that there were any issues with this product. An allergen statement was also reviewed for the flavoring used in the zooby prophy paste - happy hippo cake, medium. The statement indicated that the flavoring did not contain any of the major food based allergens, which included a statement specifically calling out tree nuts (almonds). Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[39928704]
A complaint was received of a patient having an allergic reaction to the zooby prophy paste - happy hippo cake, medium. The patient is (b)(6) years old. The only known allergen of the patient is almond oil. She developed bumps on the side of her tongue and her cheeks swelled. She did not need medical attention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1941138-2016-00010 |
| MDR Report Key | 5486729 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-03-08 |
| Date of Report | 2016-03-04 |
| Date of Event | 2016-03-02 |
| Date Mfgr Received | 2016-03-02 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| 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 | ZOOBY PROPHY PASTE - HAPPY HIPPO CAKE, MEDIUM |
| Generic Name | PROPHY PASTE |
| Product Code | EJR |
| Date Received | 2016-03-08 |
| Model Number | 603110 |
| Catalog Number | 603110 |
| Lot Number | 13241 |
| Device Expiration Date | 2017-08-31 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 |