MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2016-03-08 for ZOOBY PROPHY PASTE - GROWLIN' GRRRAPE, MEDIUM 602110 manufactured by Young Dental Manufacturing Co 1, Llc.
[39887817]
A (b)(6) year old had an allergic reaction believed to be in response to the zooby prophy paste - growlin' grrrape, medium. The patient developed a rash over her entire body. She is seeking medical attention with an allergist and young dental manufacturing co 1, llc. Provided them with the ingredient list of the product. 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.
Patient Sequence No: 1, Text Type: N, H10
[39887818]
A (b)(6) year old had an allergic reaction to zooby prophy paste - growlin' grrrape, medium (rash all over body). She is seeing an allergist. A complete list of ingredients was provided to the allergist by young dental manufacturing co 1, llc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1941138-2016-00011 |
| MDR Report Key | 5486194 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2016-03-08 |
| Date of Report | 2016-03-04 |
| Date of Event | 2016-03-04 |
| Date Mfgr Received | 2016-03-04 |
| 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 - GROWLIN' GRRRAPE, MEDIUM |
| Generic Name | PROPHY PASTE |
| Product Code | EJR |
| Date Received | 2016-03-08 |
| Model Number | 602110 |
| Catalog Number | 602110 |
| Lot Number | 16393 |
| 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 |