MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-09-22 for ZOOM WHITENING LAMP AND PROCEDURE KIT 25% ZM2604R manufactured by Discus Dental, Llc.
[21296229]
The event occurred on (b)(6) 2011; however, it was formally reported to discus dental from dr. (b)(6) on (b)(6) 2011. Prior to procedure, pt was given/took 800 mg. Motrin. During the procedure, the pt requested to stop procedure due to discomfort (zingers). Pt left office; claimed sensitivity (zingers) continued for next 72 hours. After the procedure was stopped, the dentist office called in an rx for 800 mg. Motrin/ibuprofen and advised to take motrin every 6 hours. Pt went to emergency room the same evening of (b)(6) 2011 and was prescribed hydromorphone/dilaudid. On (b)(6) 2011 dr. (b)(6) provided relief gel with acp and fluoride gel/toothpaste; all discus dental products. As of the complaint date ((b)(6) 2011) pt claims consistent aching on lower arch and discomfort with cool air and cold/hot drinks.
Patient Sequence No: 1, Text Type: D, B5
[21518328]
Reviewed the dhr for the zoom whitening system. The lamp used in the procedure was within manufacturing specifications upon shipment to the customer. The retain sample of the chair side gel used in the procedure (and is directly applied to the teeth) was within all manufacturing specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032714-2011-00008 |
| MDR Report Key | 2326936 |
| Report Source | 05 |
| Date Received | 2011-09-22 |
| Date of Report | 2011-09-19 |
| Date of Event | 2011-06-22 |
| Date Facility Aware | 2011-06-22 |
| Report Date | 2011-09-19 |
| Date Reported to Mfgr | 2011-08-25 |
| Date Mfgr Received | 2011-08-25 |
| Device Manufacturer Date | 2011-05-17 |
| Date Added to Maude | 2012-07-12 |
| 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 25% |
| Product Code | EEG |
| Date Received | 2011-09-22 |
| Model Number | ZM2604R |
| Catalog Number | ZM2604R |
| Lot Number | 11150017 |
| ID Number | 1297/1071 |
| Device Expiration Date | 2012-10-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 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 | 0 | 1. Hospitalization | 2011-09-22 |