MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-01 for BURKHART PRIVATE LABEL ADVANTAGE SALIVA EJECTOR ZWWIBK manufactured by Crosstex.
[25399466]
The dental facility reported that while using the cavitron, the patient went to close down their mouth for suction and the saliva ejector tip popped off in his mouth. No patient injury or illness as a result. Crosstex qa and manufacturing evaluations are underway and crosstex is still in close communication with the distributor. This complaint will continue to be monitored within crosstex complain handling system.
Patient Sequence No: 1, Text Type: N, H10
[25399467]
The dental facility reported that while using the cavitron, the patient went to close down their mouth for suction and the saliva ejector tip popped off in his mouth. No patient injury or illness reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2433773-2015-00002 |
| MDR Report Key | 5048031 |
| Date Received | 2015-09-01 |
| Date of Report | 2015-09-01 |
| Date of Event | 2015-08-25 |
| Date Mfgr Received | 2015-08-31 |
| Device Manufacturer Date | 2015-06-15 |
| Date Added to Maude | 2015-09-01 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MEGAN DICKEY |
| Manufacturer Street | 10 RANICK RD |
| Manufacturer City | HAUPPAGE NY 11788 |
| Manufacturer Country | US |
| Manufacturer Postal | 11788 |
| Manufacturer Phone | 7635533327 |
| Manufacturer G1 | CROSSTEX |
| Manufacturer Street | 10 RANICK RD |
| Manufacturer City | HAUPPAUGE NY 11788 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11788 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BURKHART PRIVATE LABEL ADVANTAGE SALIVA EJECTOR |
| Generic Name | SALIVA EJECTOR |
| Product Code | DYN |
| Date Received | 2015-09-01 |
| Model Number | ZWWIBK |
| Lot Number | 0615151 |
| Operator | DENTAL HYGIENIST |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CROSSTEX |
| Manufacturer Address | 10 RANICK RD HAUPPAUGE NY 11788 US 11788 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-01 |