| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ZOOM CHAIRSIDE WHITENING | ZOOM CHAIRSIDE KIT | DISCUS DENTAL, LLC | EEG | ZOOM 2.6 | ZM2613P | 13315047 | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-05-23 | 0 | 1. O |
Patient 1
DR (B)(6) CALLED ON (B)(6) 2014 AND SAID THAT A PT HAD A WHITENING PROCEDURE DONE AND ABOUT THREE HOURS LATER, THE LIPS BECAME SWOLLEN. SHE WENT TO THE EMERGENCY ROOM AND RECEIVED PAIN MEDICATION AND BENADRYL. DR (B)(6) THINKS IT WAS AN ALLERGIC REACTION.
Patient 1
THE INVESTIGATION INCLUDED REVIEW OF THE BATCH HISTORY RECORD FOR THE SKU (B)(4), LOT# 13315047. THE REVIEW OF THE BATCH HISTORY RECORDS DID NOT UNCOVER ANY ADVERSE FINDING. IN ADDITION, THE RETAIN SAMPLE FOR SKU# (B)(4), LOT# 13315047 WAS TESTED AND WAS FOUND TO BE WITHIN SPECS. NO OTHER QUALITY ISSUES WERE REVEALED DURING THE REVIEW OF THE SAID RECORDS. THE ZOOM LAMP USED WITH THE ZOOM CHAIRSIDE WHITENING KIT WAS NOT RETURNED FOR EVAL. THE ZOOM LAMP WAS MFG IN 12/2007. THE RETENTION TIME FOR THE DEVICE HISTORY RECORD FOR THE ZOOM LAMP IS 5 YEARS. THEREFORE, THE DEVICE HISTORY RECORD IS NO LONGER AVAILABLE FOR REVIEW. BASED ON THE INVESTIGATION AND INFO PROVIDED, IT APPEARS THAT THE INCIDENT DESCRIBED IN THE COMPLAINT MIGHT BE DUE TO TOO THIN LIQUIDAM APPLIED TO THE GUMS OR IMPROPER ISOLATION OF THE GINGIVA. SINCE THE PT SOUGHT MEDICAL ATTENTION, THIS EVENT WILL BE REPORTED TO THE FDA. DISCUS WILL CONTINUE TO MONITOR THE CUSTOMER COMPLAINTS FOR SIMILAR ISSUE.