MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2018-05-14 for VARNISH PEN - ASSORTED 295782 manufactured by Young Dental Manufacturing I, Llc.
[108227079]
A patient returned for a follow up appointment after her hygiene appointment a week before. Following the appointment, she broke out in sores on the inside of her lips and thinks it is due to the varnish pen. She hasn't had varnish used for over 2 years and has a known history of latex/rubber allergy. The varnish pen was used on her, which was the only new thing used. All other products used have been used on her before. The patient is female in her (b)(6) and has been taking benadryl to treat the sores. The sores were still present during the follow up appointment. The varnish pen is comprised of varnish, an aluminum tube, and plastic. There is no known presence of latex in the makeup of these parts. There is no evidence that suggests the possible reaction was due to the varnish pen. Benadryl was used to reduce the effects of the possible allergic reaction that occured after the hygiene appointment. It has not been concluded that impairment or permanent damage could have occurred if medication had not been used. However, since an additional precaution was used, we believe the event is reportable. This event did not result in serious injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1941138-2018-00001 |
| MDR Report Key | 7512257 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2018-05-14 |
| Date of Report | 2018-05-14 |
| Date of Event | 2018-04-25 |
| Date Mfgr Received | 2018-05-01 |
| Date Added to Maude | 2018-05-14 |
| 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 | DENTAL HYGIENIST |
| 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 | VARNISH PEN - ASSORTED |
| Generic Name | VARNISH |
| Product Code | LBH |
| Date Received | 2018-05-14 |
| Model Number | 295782 |
| Operator | DENTAL HYGIENIST |
| 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. Other | 2018-05-14 |