MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2007-10-11 for ELMEX WAX WB-ELMEX manufactured by Dentsply Glenroe.
[706202]
It was reported that a patient developed reddening, burning, irritation, and large hives on the gingival tissue and back, eyes, and stomach within a few hrs of using elmex wax. The pt discontinued use and consulted a physician who administered solupred (cortisone) and vizal (an antihistamine). Also, the physician tested the pt for food allergies with negative results; further allergy tests are planned, though results are not available as of this report.
Patient Sequence No: 1, Text Type: D, B5
[7879271]
While it is unknown, if the wax used in this case caused or contributed to the pt's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material. Further, a steroid and an antihistamine were administered as a result. Therefore, this event is reportable per 21 cfr part 803. A dhr review conducted indicates that the product was manufactured according to specifications. Also, the supplier noted that the wax is derived entirely from petroleum hydrocarbons and does not contain any allergens.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036212-2007-00165 |
| MDR Report Key | 925632 |
| Report Source | 01,05 |
| Date Received | 2007-10-11 |
| Date of Report | 2007-09-11 |
| Date of Event | 2007-09-11 |
| Date Mfgr Received | 2007-09-11 |
| Date Added to Maude | 2007-10-16 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | SUSQUEHANNA COMMERCE CENTER W 221 W PHILA. ST., STE 60 |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY GLENROE |
| Manufacturer Street | 1912 44TH AVE., EAST |
| Manufacturer City | BRADENTON FL 34203 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34203 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELMEX WAX |
| Generic Name | EGD |
| Product Code | EGD |
| Date Received | 2007-10-11 |
| Model Number | NA |
| Catalog Number | WB-ELMEX |
| Lot Number | WO-094909 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 898850 |
| Manufacturer | DENTSPLY GLENROE |
| Manufacturer Address | BRADENTON FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-10-11 |