MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-11-07 for PHILIPS ZOOM 881055701540 manufactured by Discus Dental, Llc.
[91290838]
Discus dental received a complaint on (b)(4) 2017 in which dental hygienist reported that after in-office teeth whitening procedure, patient felt nauseous and went to hospital after vomiting blood. The patient also experienced burning on tongue and roof of the mouth. The dental assistant stated that the patient swallowed the gel and had a lot of salivation during the whitening procedure. Investigation: the product was used up during the procedure and not available for return. The retain sample of the zoom whitening gel, sku: (b)(4), lot: 17243014 was tested on 10/17/2017 and results were within specifications. Reviewed device history records of zoom whitening kit, sku: 881055701540, udi: (01)(b)(4), lot: 17243005, and zoom whitening gel, sku: (b)(4), lot: 17243014 and no out of specification or discrepancy was found in the records. Reviewed complaints history, no other similar incidents were reported from the same lots. Based on the investigation results and available information, it can be concluded that there was no failure and malfunction in the device. Heavy salivation and swallowing the gel may have contributed to the event. Based on the investigation results, no product failure and out of specification was found and no corrective action is needed. Dfu is adequate and it describes first aid instructions if gel is swallowed, proper isolation steps, candidate qualification, warnings, ingredients, and other precautions. Product was used up during the procedure.
Patient Sequence No: 1, Text Type: N, H10
[91290839]
Discus dental received a complaint on (b)(4) 2017 in which dental hygienist reported that after in-office teeth whitening procedure, patient felt nauseous and went to hospital after vomiting blood. The patient also experienced burning on tongue and roof of the mouth. The dental assistant stated that the patient swallowed the gel and had a lot of salivation during the whitening procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000582314-2017-00009 |
| MDR Report Key | 7008133 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-11-07 |
| Date of Report | 2017-11-07 |
| Date of Event | 2017-10-12 |
| Date Mfgr Received | 2017-10-12 |
| Device Manufacturer Date | 2017-09-01 |
| Date Added to Maude | 2017-11-07 |
| 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 | 2017-11-07 |
| Model Number | 881055701540 |
| Lot Number | 17243005 |
| Device Expiration Date | 2018-12-02 |
| 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. Hospitalization | 2017-11-07 |