MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-06-20 for PHILIPS ZOOM 881055601540 manufactured by Discus Dental, Llc.
[111831346]
Discus dental received a complaint on 05/24/2018, in which dental assistant reported that in office teeth whitening gel dripped onto patient's mandible. Patient experienced swollen white/grey cervical margins. Dentist recommended magic mouthwash, peroxyl and canker sore otc drug. Patient is doing better, patient continues to use vitamin e oil and magic mouthwash. Reviewed direction for use of the in-office whitening zoom chairside kit. It describes the steps for proper isolation of soft tissue to prevent burn and irritation. It also includes candidate qualification, safety directions, warnings, and precautions. Reviewed device history records for whitening gel part number 22-3764, lot number 18060002, and zoom whitening kit part number 881055601540, lot number 18060004, and no out of specification or discrepancy was found. Tested the retain sample of the whitening gel 22-3764, lot 18060002, and no product failure was detected. Reviewed customer complaints history for 2018, no similar complaints from the same lots. With the available information, discus dental concludes there was no malfunction or failure in the product. No corrective actions are required. The potential cause of this incident can be failure to follow the instructions provided with the product. The whitening kit and gel were used.
Patient Sequence No: 1, Text Type: N, H10
[111831347]
Discus dental received a complaint on 05/24/2018, in which dental assistant reported that in office teeth whitening gel dripped onto patient's mandible. Patient experienced swollen white/grey cervical margins. Dentist recommended magic mouthwash, peroxyl and canker sore otc drug. Patient is doing better, patient continues to use vitamin e oil and magic mouthwash.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000582314-2018-00004 |
| MDR Report Key | 7623659 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-06-20 |
| Date of Report | 2018-06-20 |
| Date of Event | 2018-05-21 |
| Date Mfgr Received | 2018-05-24 |
| Device Manufacturer Date | 2018-03-01 |
| Date Added to Maude | 2018-06-20 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. SANJAY PATEL |
| Manufacturer Street | 1700 A S BAKER AVE |
| Manufacturer City | ONTARIO CA 91761 |
| Manufacturer Country | US |
| Manufacturer Postal | 91761 |
| Manufacturer Phone | 9095703508 |
| Manufacturer G1 | DISCUS DENTAL, LLC |
| Manufacturer Street | 1700 A SOUTH BAKER AVE |
| Manufacturer City | ONTARIO CA 91761 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91761 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILIPS ZOOM |
| Generic Name | ZOOM CHAIRSIDE WHITENING KIT AND GEL |
| Product Code | EEG |
| Date Received | 2018-06-20 |
| Model Number | 881055601540 |
| Catalog Number | 881055601540 |
| Lot Number | 18060004 |
| Device Expiration Date | 2019-12-11 |
| Operator | DENTAL ASSISTANT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DISCUS DENTAL, LLC |
| Manufacturer Address | 1700 A SOUTH BAKER AVE ONTARIO CA 91761 US 91761 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-20 |