MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-04-13 for VANISH 5% SODIUM FLUORIDE WHITE VARNISH 12150L manufactured by 3m Espe Dental Products.
[105504783]
The product used by this office was not returned to 3m oral care for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[105504784]
On (b)(6) 2018, a dentist reported that a (b)(6) female patient experienced shortness of breath within 5 minutes after application of 3m espe vanish? 5% sodium fluoride white varnish (melon flavor); the dentist had the patient rinse and brush off the varnish prior to leaving the office. The patient went to the emergency room later that same day, where benadryl was administered intravenously and one epinephrine injection was administered. Other products used during the dental appointment included a non-3m brand of prophy paste. Current patient status is fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2018-00002 |
| MDR Report Key | 7430871 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-04-13 |
| Date of Report | 2018-04-13 |
| Date of Event | 2018-04-10 |
| Date Mfgr Received | 2018-04-10 |
| Date Added to Maude | 2018-04-13 |
| 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 | SUZANNE LEUNG |
| Manufacturer Street | 2510 CONWAY AVENUE 0275-02-W -08 |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6515758052 |
| Manufacturer G1 | 3M ESPE DENTAL PRODUCTS-IRVINE |
| Manufacturer Street | 2111 MCGAW AVENUE |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VANISH 5% SODIUM FLUORIDE WHITE VARNISH |
| Generic Name | CAVITY VARNISH |
| Product Code | LBH |
| Date Received | 2018-04-13 |
| Catalog Number | 12150L |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M ESPE DENTAL PRODUCTS |
| Manufacturer Address | 2510 CONWAY AVENUE ST. PAUL MN 551441000 US 551441000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-04-13 |