MAUDE Adverse Event Report: SALTER LABS SALTER STYLE NASAL 02 CANNULA (ADULT); SOFT OXYGEN CANNULA

Model Number 16SOFT-4

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

Event Date 08/07/2014

Event Type  No Answer Provided  

Event Description

On (b)(6) 2014 salter labs received a complaint from our distributor stating a patient reported facial swelling after using our 16soft-4 cannula.

• Brand Name: SALTER STYLE NASAL 02 CANNULA (ADULT)
• Type of Device: SOFT OXYGEN CANNULA
• Manufacturer (Section D): SALTER LABS; 2365 camino vida roble; carlsbad CA 92011
• Manufacturer Contact: aurelia brownridge ; 2365 camino vida roble; carlsbad, CA 92011 ; 7607957102
• MDR Report Key: 4116987
• MDR Text Key: 4700735
• Report Number: 3000219639-2014-00005
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 16SOFT-4
• Device Catalogue Number: 16SOFT-4-50
• Device Lot Number: 050514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 89 YR