MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-05-23 for ZOOM CHAIRSIDE WHITENING ZOOM 2.6 ZM2613P manufactured by Discus Dental, Llc.
[4450314]
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 Sequence No: 1, Text Type: D, B5
[11894138]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000582314-2014-00004 |
| MDR Report Key | 3830509 |
| Report Source | 05 |
| Date Received | 2014-05-23 |
| Date of Report | 2014-03-11 |
| Date of Event | 2014-02-19 |
| Date Mfgr Received | 2014-02-19 |
| Date Added to Maude | 2014-05-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CARMELITA TORRES |
| Manufacturer Street | 1700A SOUTH BAKER AVE. |
| Manufacturer City | ONTARIO CA 91761 |
| Manufacturer Country | US |
| Manufacturer Postal | 91761 |
| Manufacturer Phone | 9095703512 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZOOM CHAIRSIDE WHITENING |
| Generic Name | ZOOM CHAIRSIDE KIT |
| Product Code | EEG |
| Date Received | 2014-05-23 |
| Model Number | ZOOM 2.6 |
| Catalog Number | ZM2613P |
| Lot Number | 13315047 |
| Device Expiration Date | 2015-04-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DISCUS DENTAL, LLC |
| Manufacturer Address | ONTARIO CA 91761 US 91761 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-05-23 |