MAUDE Adverse Event Report: YOUNG DENTAL MANUFACTURING I, LLC ZOOBY; PROPHYLAXIS PASTE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anaphylactic Shock (1703); Sore Throat (2396); Patient Problem/Medical Problem (2688)

Event Date 03/07/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, young dental customer service was contacted by an employee of a dental office to report the following occurrence: a patient, female, age (b)(6), complained of a "scratchy throat" after the hygienist performed prophylactic cleaning of the patient's teeth.The patient thought her throat was swelling.The product used on the patient was zooby brand "happy hippo cake" prophylaxis paste.The hygienist suggested that the patient seek medical attention.The patient did not seek medical attention.Young dental customer service provided allergen information and safety data sheet for this product.The date of this patient's dental office visit was not provided.The unique identification number of the product used on the patient was not provided.A lot number associated with the product used on the patient was not provided.Any known allergies, pre-existing conditions, or history of similar reactions for this patient were not provided.Young dental customer service requested additional information from the dental office involved in this event on (b)(6) 2019 and (b)(6) 2019.The dental office has not responded to these attempts to obtain more information.As of 03/14/2019, young dental has received no further information from the dental office involved in this adverse event.

• Brand Name: ZOOBY
• Type of Device: PROPHYLAXIS PASTE
• Manufacturer (Section D): YOUNG DENTAL MANUFACTURING I, LLC; 13705 shoreline court east; earth city MO 63045
• Manufacturer Contact: jose espino ; 13705 shoreline court east; earth city, MO 63045 ; 3143440010
• MDR Report Key: 8449489
• MDR Text Key: 139754081
• Report Number: 1941138-2019-00002
• Device Sequence Number: 1
• Product Code: EJR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2019
• 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): Life Threatening
• Patient Age: 30 YR