MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2007-10-26 for DENTAURUM WAX WB-DENT manufactured by Dentsply Glenroe.
[709210]
It was reported that a patient had an allergic reaction to dentaurum wax. Further information has been requested, though none is available after several unsuccessful follow-up attempts.
Patient Sequence No: 1, Text Type: D, B5
[8013917]
While it is unk if the wax used in this case caused or contributed to the patient'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. Therefore, this event is reportable per 21 cfr part 803. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036212-2007-00190 |
| MDR Report Key | 933169 |
| Report Source | 01,08 |
| Date Received | 2007-10-26 |
| Date of Report | 2007-09-28 |
| Date of Event | 2007-09-28 |
| Date Mfgr Received | 2007-09-28 |
| Date Added to Maude | 2007-10-31 |
| 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 | 0 |
| 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 | DENTAURUM WAX |
| Product Code | EGD |
| Date Received | 2007-10-26 |
| Model Number | WAX |
| Catalog Number | WB-DENT |
| Lot Number | UNK |
| 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 | 906631 |
| Manufacturer | DENTSPLY GLENROE |
| Manufacturer Address | BRADENTON FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-10-26 |