MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-28 for VANISH 5% SODIUM FLUORIDE WHITE VARNISH 12419L manufactured by 3m Espe Dental Products.
[74009366]
The product used by this office was not returned to 3m oral care for evaluation. However, based on the lot number provided, ftir analytical testing of a retain sample from the same lot showed no unusual or missing peaks when compared to a control lot, which indicates the product was of intended composition.
Patient Sequence No: 1, Text Type: N, H10
[74009367]
On (b)(6) 2017, a registered dental hygienist reported that two brothers, (b)(6), were taken to the emergency room around midnight on (b)(6) 2017 where iv fluids were administered for dehydration. It was reported that the boys had vomited following an application 3m espe vanish? 5% sodium fluoride white varnish (melon flavor) earlier the same day. Prior to application of the vanish varnish, the patients received a prophy using a fluoride-containing paste.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2017-00037 |
| MDR Report Key | 6530997 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-04-28 |
| Date of Report | 2017-04-06 |
| Date of Event | 2017-03-21 |
| Date Mfgr Received | 2017-04-06 |
| Date Added to Maude | 2017-04-28 |
| 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 | ANGIE DRAPER |
| Manufacturer Street | 2510 CONWAY AVENUE |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517331179 |
| 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 | 2017-04-28 |
| Catalog Number | 12419L |
| Lot Number | 807706 |
| Operator | DENTAL HYGIENIST |
| 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 | 2017-04-28 |