MAUDE Adverse Event Report: YOUNG DENTAL MANUFACTURING CO 1, LLC ZOOBY PROPHY PASTE - GROWLIN' GRRRAPE, MEDIUM

Model Number 602110

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Rash (2033); Reaction (2414)

Event Date 03/04/2016

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: ZOOBY PROPHY PASTE - GROWLIN' GRRRAPE, MEDIUM
• Type of Device: PROPHY PASTE
• Manufacturer (Section D): YOUNG DENTAL MANUFACTURING CO 1, LLC; 13705 shoreline court e.; earth city MO 63045
• Manufacturer (Section G): YOUNG DENTAL MANUFACTURING CO 1, LLC; 13705 shoreline court e.; earth city MO 63045
• Manufacturer Contact: sarah moore ; 13705 shoreline court e.; earth city, MO 63045 ; 3143440010
• MDR Report Key: 5486194
• MDR Text Key: 39887817
• Report Number: 1941138-2016-00011
• Device Sequence Number: 1
• Product Code: EJR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 602110
• Device Catalogue Number: 602110
• Device Lot Number: 16393
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 3 YR