MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-10-28 for ZOOM WHITENING LAMP AND PROCEDURE KIT ZM2613 manufactured by Discus Dental, Llc.
[20913540]
After the third (3 of 4) sessions of the chair side whitening treatment, the pt complained of a lot of tooth sensitivity.
Patient Sequence No: 1, Text Type: D, B5
[21148673]
The device history record was reviewed and the light output for the lamp used in the procedure was within mfg specifications at time of shipment. In addition, a retain sample of the whitening gel used in the procedure was assayed and was found to be within all mfg specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032714-2011-00009 |
| MDR Report Key | 2389914 |
| Report Source | 05 |
| Date Received | 2011-10-28 |
| Date of Report | 2011-10-28 |
| Date of Event | 2011-09-29 |
| Date Facility Aware | 2011-09-29 |
| Report Date | 2011-10-28 |
| Date Reported to Mfgr | 2011-09-29 |
| Date Mfgr Received | 2011-09-29 |
| Device Manufacturer Date | 2007-05-30 |
| Date Added to Maude | 2012-07-16 |
| 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 | 8550 HIGUERA ST. |
| Manufacturer City | CULVER CITY CA 90232 |
| Manufacturer Country | US |
| Manufacturer Postal | 90232 |
| Manufacturer Phone | 3108458336 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZOOM WHITENING LAMP AND PROCEDURE KIT |
| Product Code | EEG |
| Date Received | 2011-10-28 |
| Model Number | ZM2613 |
| Catalog Number | ZM2613 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DISCUS DENTAL, LLC |
| Manufacturer Address | CULVER CITY CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-10-28 |