MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-12-09 for WH AND SEALER GEL WITH SYRING QUICKPRO manufactured by .
[15126161]
After completing the quikpro teeth whitening procedure, the consumer complained that the gel was too sticky/gummy and when she wiped it off with the gauze, it came in contact with the nail bed and felt a burning sensation. The consumer went to see a dermatologist and she was given a steroid.
Patient Sequence No: 1, Text Type: D, B5
[15397173]
After completing the quickpro teeth whitening procedure, the consumer complained that the gel was too sticky/gummy and when she wiped it off with the gauze, it came in contact with the nail bed and felt a burning sensation. The consumer went to see a dermatologist and she was given a steroid. The investigation included review of the batch history records for the sku # (b)(4) lot # 14281019. The review of the batch history records did not uncover any adverse finding. In addition, the retain sample for sku # (b)(4), lot # 14281019 was tested and was found to be within specifications. No returned sample was received form the customer no other quality issues were revealed during the review of the said records. Based on the results of the investigation, it has been determined that this is a reportable event discus dental will continue to monitor similar issues.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000582314-2014-00013 |
| MDR Report Key | 4309825 |
| Report Source | 05 |
| Date Received | 2013-12-09 |
| Date of Report | 2014-11-14 |
| Date Mfgr Received | 2014-10-22 |
| Date Added to Maude | 2014-12-12 |
| 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 | 0 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CARMELITA TORRES |
| Manufacturer Street | 1700A SOUTH BAKER AVE |
| Manufacturer City | ONTARIO CA 91761 |
| Manufacturer Country | US |
| Manufacturer Postal | 91761 |
| Manufacturer Phone | 9095703512 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WH AND SEALER GEL WITH SYRING QUICKPRO |
| Generic Name | NONE |
| Product Code | EEG |
| Date Received | 2013-12-09 |
| Lot Number | 14281019 |
| Device Expiration Date | 2015-03-01 |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-12-09 |