D
Patient 1
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.
MAUDE MDR 4907329
- MDR report key
- 4907329
- Report number
- 2433773-2015-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-07-09
- Date received
- 2015-07-10
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- KRISTIN BERGESON
- Address
- 10 RANICK RD HAUPPAGE NY 11788 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-07-10 | 0 | 1. O; 2. R |
Event Narratives#
N
Patient 1
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.
N
Patient 1
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).
D
Patient 1
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.