MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-12-12 for PHILIPS ZOOM 881055701540 manufactured by Discus Dental, Llc.
[94631251]
Discus dental received a complaint on (b)(4) 2017 in which the dental office manager reported that the gel from take home teeth whitening syringe got into his eye when he was closing the syringe. He rinsed his eye with water, and since the eye was still red after the incident he visited a doctor. He responded later the same day that he is ok. Investigation: the retain sample of the take home whitening gel, sku: (b)(4), lot: 17279015 was tested on 11/21/2017 and results were within specifications. Reviewed device history records of zoom whitening kit, sku: (b)(4), lot: 17299012, and take home whitening gel, sku: (b)(4), lot: 17279015 and no out of specification or discrepancy was found in the records. Reviewed complaints history, no other similar incidents were reported since january 2015. No other similar incident was reported from all finished kits that take home whitening gel, sku: (b)(4), lot: 17279015 was used. Based on the investigation results and available information, it can be concluded that there was no failure and malfunction in the device. Potential cause will be user error and applying pressure to the plunger when closing the syringe cap. Zoom take home dfu is adequate and it describes the warnings and precautions when handling the take home syringe (section 4), and first aid instructions if gel gets into eyes (section 5). " warnings: remove cap safely, contents may be under pressure. Risk of serious damage to the eyes. First aid instructions:... If hydrogen peroxide (hp) or carbamide peroxide (cp) gel gets into eyes, on skin or hair, flush with running water. " based on the investigation results, no product failure and out of specification was found. Dfu is adequate and no corrective action is needed.
Patient Sequence No: 1, Text Type: N, H10
[94631252]
Discus dental received a complaint on (b)(4) 2017 in which the dental office manager reported that the gel from take home teeth whitening syringe got into his eye when he was closing the syringe. He rinsed his eye with water, and since the eye was still red after the incident (no burning), he visited a doctor. He responded later the same day that he is ok.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000582314-2017-00010 |
| MDR Report Key | 7111519 |
| Report Source | OTHER |
| Date Received | 2017-12-12 |
| Date of Report | 2017-12-12 |
| Date of Event | 2017-11-17 |
| Date Mfgr Received | 2017-11-17 |
| Device Manufacturer Date | 2017-10-30 |
| Date Added to Maude | 2017-12-12 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. SANJAY PATEL |
| Manufacturer Street | 1700 A SOUTH 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 |
| Product Code | EEG |
| Date Received | 2017-12-12 |
| Model Number | 881055701540 |
| Lot Number | 17299012 |
| Device Expiration Date | 2019-02-23 |
| 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 | 2017-12-12 |