MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-10-05 for ZOOM NITEWHITE 16% ZNW1006 NA manufactured by Discus Dental, Llc.
[15513834]
Patient complained that after 3 applications (uses) of the take home , whitening gel caused swelling and irritation in her throat. Her dentist advised that she seek her pcp (personal care physician). Patient did visit her doctor and they were unable to find a reason for the swelling and irritation. The patient has discontinued use of the product.
Patient Sequence No: 1, Text Type: D, B5
[15749530]
The dfu was reviewed for warnings and cautions. It does state how to fill the trays (to avoid overfilling). It also notes that it is harmful if swallowed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032714-2012-00003 |
| MDR Report Key | 2818422 |
| Report Source | 05 |
| Date Received | 2012-10-05 |
| Date of Report | 2012-10-05 |
| Date of Event | 2012-09-11 |
| Date Facility Aware | 2012-09-11 |
| Report Date | 2012-10-05 |
| Date Reported to Mfgr | 2012-09-11 |
| Date Mfgr Received | 2012-09-11 |
| Device Manufacturer Date | 2012-05-06 |
| Date Added to Maude | 2012-11-16 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | 12121 W. BLUFF DRIVE |
| Manufacturer City | LOS ANGELES CA 90094 |
| Manufacturer Country | US |
| Manufacturer Postal | 90094 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZOOM NITEWHITE 16% |
| Generic Name | NONE |
| Product Code | EEG |
| Date Received | 2012-10-05 |
| Model Number | ZNW1006 |
| Catalog Number | NA |
| Lot Number | 12128020 |
| ID Number | 1287/1071 |
| Device Expiration Date | 2013-09-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DISCUS DENTAL, LLC |
| Manufacturer Address | LOS ANGELES CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-10-05 |