MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-03-25 for ZOOBY manufactured by Young Dental Manufacturing I, Llc.
[139754081]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1941138-2019-00002 |
| MDR Report Key | 8449489 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-03-25 |
| Date of Report | 2019-03-14 |
| Date of Event | 2019-03-07 |
| Date Mfgr Received | 2019-03-07 |
| Date Added to Maude | 2019-03-25 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOSE ESPINO |
| Manufacturer Street | 13705 SHORELINE COURT EAST |
| Manufacturer City | EARTH CITY MO 63045 |
| Manufacturer Country | US |
| Manufacturer Postal | 63045 |
| Manufacturer Phone | 3143440010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZOOBY |
| Generic Name | PROPHYLAXIS PASTE |
| Product Code | EJR |
| Date Received | 2019-03-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | YOUNG DENTAL MANUFACTURING I, LLC |
| Manufacturer Address | 13705 SHORELINE COURT EAST EARTH CITY MO 63045 US 63045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2019-03-25 |