D
Patient 1
THE CUSTOMER REPORTED THAT A PATIENT DEVELOPED SWOLLEN RED LIPS AFTER A WHITENING PROCEDURE. LOOKED LIKE BURNS. PATIENT SOUGHT MEDICAL HELP. THE DOCTOR SAID PATIENT HAD SECOND DEGREE BURNS.
MAUDE MDR 3576811
- MDR report key
- 3576811
- Report number
- 1000582314-2013-00007
- Event key
- 0
- Event type
- 3
- Date of event
- 2013-10-31
- Date received
- 2013-12-30
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- CARMELITA TORRES, SR MGR
- Address
- 1700 A SOUTH BAKER AVE. ONTARIO CA 91761 US
- Phone
- 909-909-9095
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ZOOM CHAIRSIDE WHITENING KIT | NA | DISCUS DENTAL LLC | EEG | ZOOM AP | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-12-30 | 0 | 1. O |
Event Narratives#
N
Patient 1
THE INVESTIGATION INCLUDED REVIEW OF THE BATCH HISTORY RECORDS FOR THE SKY # 22-3764 LOT # 13140026. THE REVIEW OF THE BATCH HISTORY RECORDS DID NOT UNCOVER ANY ADVERSE FINDING. IN ADDITION, THE RETAIN SAMPLE FOR SKU # 22-3764 LOT # 13140026 WAS TESTED AND WAS FOUND TO BE WITHIN SPECIFICATIONS. RETURNED SAMPLE WAS REC'D FROM THE CUSTOMER AND WAS SENT TO THE QC LAB FOR TESTING BUT THERE WAS NOT ENOUGH SAMPLE TO PERFORM THE REQUIRED TESTING. NO OTHER QUALITY ISSUES WERE REVEALED DURING THE REVIEW OF THE SAID RECORDS. THE INVESTIGATION ALSO INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD FOR THE ZOOM AP LAMP, SERIAL # (B)(4) AND WAS FOUND TO BE WITHIN MANUFACTURING SPECIFICATIONS AT THE TIME OF SHIPMENT. THE REVIEW OF THE DEVICE HISTORY RECORD DID NOT UNCOVER ANY ADVERSE FINDING.