MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-07-09 for ZOOM AP LAMP ZM2500 manufactured by Discus Dental, Llc.
[4584680]
Hold -sdaon 05/20/2014, chris from the dental clinic called about a patient that had an ulcer on the gingiva of the bottom jaw from using the small grey color retractor. They stated that the patient had a hard time getting the small retractor in as it was still too big for this patient. They also stated that the patient is in pain and has been rinsing with warm water and salt. Patient also complained of sensitively, the dental office gave the patient a cream.
Patient Sequence No: 1, Text Type: D, B5
[11914827]
The investigation included review of batch history record for zm2666 zoom ch kit lot # 13336048 (chairside gel 22-3764 lot # 13350030). The review of the batch history record did not uncover any adverse finding. In additional, the retain sample for sku # 22-3764 lot #13350030 was tested and it was found to be within specifications. No other quality issue was revealed during the review of said records. The device history record for the zoom ap lamp, zm2500 serial # 02376 is not available for review since the lamp was manufactured in 2005 and the record retention for the dhr is five years. Discus dental will continue to monitor similar issues. See scanned pages.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000582314-2014-00011 |
| MDR Report Key | 3927368 |
| Report Source | 99 |
| Date Received | 2014-07-09 |
| Date of Report | 2014-06-12 |
| Date Mfgr Received | 2014-05-20 |
| Device Manufacturer Date | 2005-05-01 |
| Date Added to Maude | 2014-07-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CARMELITA TORRES |
| Manufacturer Street | 1700 A SOUTH BAKER AVE. |
| Manufacturer City | ONTARIO CA 91761 |
| Manufacturer Country | US |
| Manufacturer Postal | 91761 |
| Manufacturer Phone | 9095703512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZOOM AP LAMP |
| Generic Name | WHITENING LAMP |
| Product Code | EEG |
| Date Received | 2014-07-09 |
| Model Number | ZM2500 |
| 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 | ONTARIO CA 91761 US 91761 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-07-09 |