MAUDE Adverse Event Report: ORIDION MEDICAL SMART CAPNOLINE

Model Number 010210

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Numbness (2415)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a procedure, the patient developed an allergy to the product material.It was stated that the patient experienced perioral numbness or tingling and significant oral and throat numbness.Conscious sedation was used but in recovery the internal reaction continued in stable way without progressing to anaphylaxis or respiratory distress.

• Brand Name: SMART CAPNOLINE
• Manufacturer (Section D): ORIDION MEDICAL; 7 hamarpeh st.; jerusalem 91235
• Manufacturer (Section G): ORIDION MEDICAL; 7 hamarpeh st.; jerusalem 91235
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 8435795
• MDR Text Key: 139827039
• Report Number: 8044004-2019-00005
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 010210
• Device Catalogue Number: 010210
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2019
• 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