MAUDE Adverse Event Report: CROSSTEX INTERNATIONAL INC. COMFORT PLUS PREMIUM SALIVA EJECTORS

Model Number ZCB

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

The user facility reported a saliva ejector tip detached from the comfort plus premium saliva ejector tube during a dental procedure.The tip was not swallowed by the patient.The patient was under local anesthetic during the procedure when the saliva ejector tip was detached.It was reported the dentist performing the procedure was able to retrieve the saliva ejector tip from the patients mouth before it was swallowed.The reported event did not cause or contribute any serious injury or deterioration of health.This event could potentially lead to serious injury if it were to recur.This complaint will be monitored in the crosstex complaint handling system.

Event Description

The user facility reported a saliva ejector tip detached from the comfort plus premium saliva ejector tube during a dental procedure.The tip was not swallowed by the patient.

• Brand Name: COMFORT PLUS PREMIUM SALIVA EJECTORS
• Type of Device: SALIVA EJECTORS
• Manufacturer (Section D): CROSSTEX INTERNATIONAL INC.; 10 ranick road; happauge NY 11788
• Manufacturer (Section G): CROSSTEX INTERNATIONAL INC.; 10 ranick road; happauge NY 11788
• Manufacturer Contact: mitchell cole ; 9800 59th ave n; plymouth, MN 55442 ; 7638984338
• MDR Report Key: 10532477
• MDR Text Key: 207796959
• Report Number: 2433773-2020-00004
• Device Sequence Number: 1
• Product Code: DYN
• UDI-Device Identifier: 50732224000676
• UDI-Public: (01)50732224000676
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZCB
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1