MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2015-06-12 for 3M ESPE SINGLES PROPHY PASTE manufactured by 3m Espe Dental Products.
[5941777]
On (b)(6) 2015, 3m espe became aware of an incident following use of multiple products that resulted in medical intervention. A (b)(6) female patient in (b)(6) received a dental treatment that included the use of: 3m espe singles prophy paste (used under it's regional tradename), 3m espe vanish 5% sodium fluoride white varnish (used under it's regional tradename) and 3m prophy powder (not sold in the u. S. And not subject of this report). The treatment was reported to have occurred sometime in the beginning of (b)(6) 2015; no further details were made available to 3m espe. Approximately 60 - 90 minutes following the dental treatment, the patient (who is also a doctor) reported that she experienced angioedema (quincke's disease). An ambulance was called and the ambulance personnel administered prednisone (reportedly by i. V. ). The patient was not transported to a hospital and is not reported to have required additional treatment; the patient's current condition is reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[13366589]
Method, results and conclusions: the product wasn't returned to 3m espe and the lot is not known. Therefore, no further analysis on the product or retained sample could be done. If 3m espe receives any additional information about this event, a follow-up report will be submitted. This product has been assessed for biocompatibility and has been found to be safe for its intended use. Since this event involved two 3m espe products which are sold in the us, two medwatch reports are being submitted. This current report refers to the first 3m espe product and report 3005174370-2015-00036 refers to the second product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005174370-2015-00035 |
| MDR Report Key | 4843564 |
| Report Source | 01,05,07 |
| Date Received | 2015-06-12 |
| Date of Report | 2015-05-14 |
| Date Mfgr Received | 2015-05-14 |
| Date Added to Maude | 2015-06-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 2510 CONWAY AVENUE |
| Manufacturer City | SAINT PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517331179 |
| Manufacturer Street | 2111 MCGAW AVE |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M ESPE SINGLES PROPHY PASTE |
| Generic Name | AGENT, POLISHING, ABRASIVE, ORAL CAV |
| Product Code | EJR |
| Date Received | 2015-06-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M ESPE DENTAL PRODUCTS |
| Manufacturer Address | SAINT PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-06-12 |