MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-03-13 for QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION QMIX60ML manufactured by Dentsply Tulsa Dental Specialities.
[19801998]
In this event it was reported that while using qmix, a patient began experiencing a tingling and burning sensation around the site. The doctor vacuumed out the qmix and the patient began experiencing swelling of the lip, then nose and by the second day the patient's eye had swollen shut. It is unknown if the patient required intervention. Follow up is not yet complete.
Patient Sequence No: 1, Text Type: D, B5
[20053247]
While it is unknown if the device 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 meets the criteria for reportability per 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 | 2515379-2015-00013 |
| MDR Report Key | 4606389 |
| Report Source | 05 |
| Date Received | 2015-03-13 |
| Date of Report | 2015-02-13 |
| Date of Event | 2015-02-13 |
| Date Mfgr Received | 2015-02-13 |
| Date Added to Maude | 2015-03-17 |
| 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 Contact | HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST., STE. 60 SUSQUEHANNA COMMERCE CTR. W. |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION |
| Product Code | KJJ |
| Date Received | 2015-03-13 |
| Catalog Number | QMIX60ML |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY TULSA DENTAL SPECIALITIES |
| Manufacturer Address | JOHNSON CITY TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-03-13 |