MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-07-28 for ZOOM WHITENING LAMP AND PROCEDURE KIT ZM2564 manufactured by Discus Dental, Llc.
[2265021]
Pt said that he was feeling zingers (tooth sensitivity) during the 3rd of 4 cycles. Wanted to continue on to 4th cycle. After the 4th cycle he continued to have sensitivity issues. Dr. Prescribed the pt vicodine. Hygienist reported the pt did not participate in the sensitivity protocol which suggests to brush with a fluoride toothpaste two weeks in advance of a chair side whitening procedure.
Patient Sequence No: 1, Text Type: D, B5
[9398768]
Reviewed the dhr for the zoom whitening system. The lamp used in the procedure was within the mfg 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 mfg specifications. The mfg work order for the was reviewed as well and no abnormalities found in the production run of the gel lot number in question. In addition an online report was submitted on (b)(4) 2011 in error. The only proof a report was submitted is attached. Fda investigator requested that an add'l report be submitted in this format and certified mail to medwatch.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032714-2011-00002 |
| MDR Report Key | 2216387 |
| Report Source | 05 |
| Date Received | 2011-07-28 |
| Date of Report | 2011-07-20 |
| Date of Event | 2011-06-06 |
| Date Facility Aware | 2011-06-06 |
| Report Date | 2011-07-20 |
| Date Reported to Mfgr | 2011-06-06 |
| Date Mfgr Received | 2011-06-06 |
| Device Manufacturer Date | 2007-01-01 |
| Date Added to Maude | 2012-06-21 |
| 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 | 2011-07-28 |
| Model Number | ZM2564 |
| Catalog Number | ZM2564 |
| Lot Number | 10321018 |
| ID Number | 1297/1071 |
| Device Expiration Date | 2012-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 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 | 2011-07-28 |