MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-10-12 for VANISH 5% SODIUM FLUORIDE WHITE VARNISH 12419M manufactured by 3m Espe Dental Products.
[57250923]
The engineering investigation was limited by lack of returned sample, but a lot number was provided. An engineering investigation was performed on a retain sample from the product lot. Ir analysis showed that there were no unusual or missing peaks when compared to a control lot, indicating product was of intended composition. It is noted that this product had been applied previously without incident, but since that application, the patient has developed allergy to corn. Vanish varnish contains ingredients derived from corn. It is also noted that the oral treatment provided is not consistent with a serious reaction of anaphylactic shock. 3m espe vanish 5% sodium fluoride white varnish has been thoroughly evaluated for biocompatibility and found to be safe for its intended use.
Patient Sequence No: 1, Text Type: N, H10
[57250924]
On (b)(6) 2016, a dental office reported that a (b)(6) female patient experienced a burning sensation in the mouth and felt like her throat was swelling and closing immediately following application of 3m espe vanish varnish. The patient took benedryl (dosage unknown) that she had brought with her for allergies, and felt better; she then left the dental office. Later that evening, the patient began to experience similar symptoms again and went to instacare and was diagnosed with anaphylactic shock (additional symptoms included rash, irritation, mouth felt hot, throat felt sore, and stomach pain) and oral steroids and an antihistamine were provided. According to the dental office, the patient called the next day ((b)(6) 2016) and reported that she was doing well; the patient reported no lingering symptoms. In addition the office reported that 3m espe vanish varnish was applied previously within the last year without incident.
Patient Sequence No: 1, Text Type: D, B5
[62738792]
Product sample (22 sachets of vanish lot #n74671) was returned to 3m for analysis. Ir analysis of the returned product showed that there were no unusual or missing peaks when compared to a control lot, indicating product was of intended composition.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005174370-2016-00109 |
| MDR Report Key | 6024926 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-10-12 |
| Date of Report | 2016-11-16 |
| Date of Event | 2016-09-13 |
| Date Mfgr Received | 2016-11-16 |
| Date Added to Maude | 2016-10-12 |
| 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 |
| 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 | 2016-10-12 |
| Returned To Mfg | 2016-11-04 |
| Catalog Number | 12419M |
| Lot Number | N746712 |
| Operator | DENTIST |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Other | 2016-10-12 |