MAUDE Adverse Event Report: SALTER LABS CANNULA; CANNULA, NASAL, OXYGEN

Model Number	16SOFT-7
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Items had overpowering smell of cigarette smoke, made sick to use.All of lot number i have are the same.Salter labs cannulas part # 16soft-7, lot #(10)210802e.No tests.Fda safety report id# (b)(4).

• Brand Name: CANNULA
• Common Device Name: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): SALTER LABS
• MDR Report Key: 14488509
• Report Number: MW5109863
• Device Sequence Number: 4735164
• Product Code: CAT
• UDI-Device Identifier: 00607411915772
• UDI-Public: (01)00607411915772
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 16SOFT-7
• Device Catalogue Number: 16SOFT-7
• Device Lot Number: (10)210802E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMLODIPINE; ARNUITY; BENADRYL ; CIALIS; EXCEDRIN; IBUPROFIN; MULTI VITAMIN; OMEPRAZOLE; OXYGEN; PREDNISONE; SINGULAIR ; STIOTTO; VENTILATOR
• Outcome Attributed to Adverse Event: Disability; Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White