MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-07-21 for ZOOM WHITENING LAMP AND PROCEDURE KIT ZM2564 manufactured by Discus Dental, Llc.
[2598992]
During the second (out of 3) zoom chair side whitening cycles the dentist had to stop because the patient had tooth sensitivity. The patient was prescribed 800mg ibuprofen.
Patient Sequence No: 1, Text Type: D, B5
[9725462]
Reviewed the dhr for the zoom whitening system. The lamp used in the procedure was within the manufacturing specifications upon shipment to the customer. The retain sample of the chair side gel used in the procedure (and goes directly on the teeth) was within all manufacturing specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032714-2011-00006 |
| MDR Report Key | 2508511 |
| Report Source | 05 |
| Date Received | 2011-07-21 |
| Date of Report | 2001-07-11 |
| Date of Event | 2011-06-16 |
| Date Facility Aware | 2011-06-16 |
| Report Date | 2011-04-04 |
| Date Reported to Mfgr | 2011-07-05 |
| Date Mfgr Received | 2011-06-16 |
| Device Manufacturer Date | 2011-04-01 |
| Date Added to Maude | 2012-06-19 |
| 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 | 0 |
| 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 | 2011-07-21 |
| Model Number | ZM2564 |
| Catalog Number | ZM2564 |
| Lot Number | NA |
| ID Number | 1297/1071 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 MO |
| 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 | 800 | 1. Other | 2011-07-21 |