MAUDE Adverse Event Report: YOUNG DENTAL MANUFACTURING 1, LLC ZOOBY GROWLIN GRAPE; PROPHY PASTE

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 11/23/2022

Event Type  Injury  

Event Description

It was the first time the patient was at the dentist for a teeth cleaning.The dentist had just started the cleaning on one tooth before the reaction, had only used the zooby growlin grape prophy paste - part number, lot number, grit level are unknown so udi is not known.Dentist was wearing gloves but the child has never had any reactions to latex before - child has come in contact with latex balloons in the past with no problem.The patient vomited immediately, developed hives and had issues breathing.An epipen was administered at the dental office and the patient was taken to the emergency room at (b)(6) hospital.It is not known if any treatment was received at the emergency room.Penicillin is the only known allergy of the patient.Mother plans to have an allergy test performed on child.

• Brand Name: ZOOBY GROWLIN GRAPE
• Type of Device: PROPHY PASTE
• Manufacturer (Section D): YOUNG DENTAL MANUFACTURING 1, LLC; 13705 shoreline ct. e; earth city MO 63045
• Manufacturer Contact: jose espino ; 13705 shoreline ct. e; earth city, MO 63045 ; 3143440010
• MDR Report Key: 16362683
• MDR Text Key: 309401840
• Report Number: 1941138-2023-00001
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• 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): Required Intervention; Other
• Patient Age: 5 YR
• Patient Sex: Male