MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-09-21 for PHILIPS ZOOM 881055601540 manufactured by Discus Dental, Llc.
[121436097]
Discus dental received a complaint on (b)(4) 2018, in which the patients face began to swell after a zoom chairside whitening procedure. The patient also developed numbness and swelling of her lower lip. The patient went to urgent care and was given dexamethasone injection, 3 doses of benadryl and was prescribed 20mlg prednisone. The kit and gel were used up during the procedure and were not returned. The retain sample of the whitening gel, sku: 22-3764, lot: 18165002, was tested on 08/31/2018, and results were within specifications. Reviewed the device/batch history records of whitening kit, sku: 881055601540, lot: 18165003 and gel, sku: 22-3764, lot: 18165002. No out of specification or discrepancy was found. Reviewed complaints history, no other similar incident was reported from the same lot numbers. Reviewed complaints history of the past 3 years. The rate for similar incidents is low. Reviewed direction for use of the kit. The dfu describes steps for candidate qualification, warnings, ingredients, and other precautions. All ingredients are listed on labeling. No product failure or out of specifications was found in the product. Potential cause may be an allergic reaction to product ingredients. Based on the investigation results and available information, discus dental concludes there was no malfunction or failure in the product. No corrective actions are required. Patient is doing much better, the swelling is gone and she is fine.
Patient Sequence No: 1, Text Type: N, H10
[121436098]
Discus dental received a complaint on (b)(4) 2018, in which the patients face began to swell after a zoom chairside whitening procedure. The patient also developed numbness and swelling of her lower lip. The patient went to urgent care and was given dexamethasone injection, 3 doses of benadryl and was prescribed 20mlg prednisone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000582314-2018-00005 |
| MDR Report Key | 7900055 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-09-21 |
| Date of Report | 2018-09-21 |
| Date of Event | 2018-08-29 |
| Date Mfgr Received | 2018-08-29 |
| Device Manufacturer Date | 2018-06-14 |
| Date Added to Maude | 2018-09-21 |
| 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 | FRANCES ESTRADA |
| Manufacturer Street | 1700A SOUTH BAKER AVE. |
| Manufacturer City | ONTARIO CA 91761 |
| Manufacturer Country | US |
| Manufacturer Postal | 91761 |
| Manufacturer Phone | 9095703542 |
| 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 KIT |
| Product Code | EEG |
| Date Received | 2018-09-21 |
| Model Number | 881055601540 |
| Lot Number | 18165003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DISCUS DENTAL, LLC |
| Manufacturer Address | 1700A SOUTH BAKER AVE. ONTARIO CA 91761 US 91761 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-21 |