MAUDE Adverse Event Report: YOUNG DENTAL MANUFACTURING CO 1, LLC ZOOBY PROPHY PASTE - HAPPY HIPPO CAKE, MEDIUM

Model Number 603110

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling (2091)

Event Date 03/02/2016

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: ZOOBY PROPHY PASTE - HAPPY HIPPO CAKE, 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: 5486729
• MDR Text Key: 39928703
• Report Number: 1941138-2016-00010
• 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: health professional
• 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 Expiration Date: 08/31/2017
• Device Model Number: 603110
• Device Catalogue Number: 603110
• Device Lot Number: 13241
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2016
• Was Device Evaluated by Manufacturer?: No
• 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: 37 YR