MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,08,distributor,health p report with the FDA on 2015-07-10 for BURKHART PRIVATE LABEL ADVANTAGE SALIVA EJECTOR ZWWIBK manufactured by Crosstex.
[18994676]
The facility reported a tip that fell off of a saliva ejector during a dental procedure. The patient aspirated the tip and it lodged in the patient's lung. Surgery was required to remove the tip.
Patient Sequence No: 1, Text Type: D, B5
[19260821]
The facility reported a tip that fell off of a saliva ejector during a dental procedure. The patient aspirated the tip and it lodged in the patient's lung. Surgery was required to remove the tip. Crosstex qa and manufacturing evaluations are underway and crosstex is still in close communication with the distributor. There are no other adverse events related to this product. Patient condition is unknown at this time. This complaint will continue to be monitored and maintained by the crosstex complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[22555775]
The facility reported a tip that fell off of a saliva ejector during a dental procedure. The patient aspirated the tip and it lodged in the patient's lung. Surgery was required to remove the tip. Crosstex qa and manufacturing evaluations are underway and crosstex is still in close communication with the distributor. There are no other adverse events related to this product. Patient condition is unknown at this time. This complaint will continue to be monitored and maintained by the crosstex complaint handling system. A voluntary recall of the problem device lot was initiated on 17 july 2015 by (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[22555776]
The facility reported a tip that fell off of a saliva ejector during a dental procedure. The patient aspirated the tip and it lodged in the patient's lung. Surgery was required to remove the tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2433773-2015-00001 |
| MDR Report Key | 4907329 |
| Report Source | 05,06,08,DISTRIBUTOR,HEALTH P |
| Date Received | 2015-07-10 |
| Date of Report | 2015-08-11 |
| Date of Event | 2015-07-09 |
| Date Mfgr Received | 2015-07-09 |
| Device Manufacturer Date | 2015-04-10 |
| Date Added to Maude | 2015-07-13 |
| 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 | KRISTIN BERGESON |
| Manufacturer Street | 10 RANICK RD |
| Manufacturer City | HAUPPAGE NY 11788 |
| Manufacturer Country | US |
| Manufacturer Postal | 11788 |
| Manufacturer G1 | CROSSTEX |
| Manufacturer Street | 10 RANICK RD |
| Manufacturer City | HAUPPAUGE NY 11788 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11788 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BURKHART PRIVATE LABEL ADVANTAGE SALIVA EJECTOR |
| Generic Name | SALIVA EJECTOR |
| Product Code | DYN |
| Date Received | 2015-07-10 |
| Model Number | ZWWIBK |
| Lot Number | 04/10/151 |
| Operator | DENTIST |
| Device Availability | * |
| Device Age | DA |
| 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 | 1. Other; 2. Required No Informationntervention | 2015-07-10 |