MAUDE Adverse Event Report: SALTER LABS SALTER LABS; ADULT NASAL CANNULA WITH 7' 3-CHANNEL TUBE - 50/CS

Model Number	16SOFT-7-50
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Superficial (First Degree) Burn (2685)
Date of Event	05/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Irritation/sores can be manifested by itching, redness, rash or in extreme cases, open sores.The salter respiratory care products are generally made from plastic/pvc, which has a good safety profile for irritation and sensitivity.A plastic product may cause irritation/sores for several reasons, including, the device has been contaminated with an external substance (e.G., mold release agent, lotions, medications) which cause irritation/sores, using device for too long (may become rough or bacterially contaminated), or individual patient-specific hypersensitivity.If the oxygen tubing is not changed out on a regular basis or as indicated on the packaging sores or irritations may result.As the patient developed burns this is reportable.
Event or Problem Description
Customer is allergic to cannula. cannula has burned customers face, eye brows, back of neck and ears.
Additional Manufacturer Narrative
Irritation/sores can be manifested by itching, redness, rash or in extreme cases, open sores.The salter respiratory care products are generally made from plastic/pvc, which has a good safety profile for irritation and sensitivity.A plastic product may cause irritation/sores for several reasons, including, the device has been contaminated with an external substance (e.G., mold release agent, lotions, medications) which cause irritation/sores, using device for too long (may become rough or bacterially contaminated), or individual patient-specific hypersensitivity.If the oxygen tubing is not changed out on a regular basis or as indicated on the packaging sores or irritations may result.As the patient developed burns this is reportable.A review of complaints submitted over the previous 24 months was conducted for product group: "9-o2 cannula" using the search terms "rash" (4), "irritation" (4), "allerg" (4) and out of that total only 3 of those complaints are related to use of the 16soft-7-50.This issue does not appear to be trending based on overall sales and an overall 12m cpm trend that is showing a downward trend.An inventory search was conducted and no inventory of this lot # remains in stock.Product has not been returned from the customer and the complaint is over 30 days old so the complaint could not be confirmed.Dhrs were reviewed for the component pieces used in this production.All records indicate the appropriate materials were used in prodcution and the in process and quality checks performed were completed and did not indicate non-conformances that would contribute to this complaint.Called the point of contact in the complaint and she stated she is allergic to a lot of things.I shared the material of construction in the cannula and that it is tested for irritation and sensitivity.The most likely root cause is patient hypersensitivity to the cannula material.Rma-20017a rev 2: r3 indicates that patient exposure to skin irritant is a extreme (7/10) severity and does not meet the threshold for carb review.
Event or Problem Description
Customer is allergic to cannula. cannula has burned customers face, eye brows, back of neck and ears.

• Brand Name: SALTER LABS
• Common Device Name: ADULT NASAL CANNULA WITH 7' 3-CHANNEL TUBE - 50/CS
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 14793376
• Report Number: 3000219639-2022-00031
• Device Sequence Number: 5195597
• Product Code: CAT
• UDI-Device Identifier: 10607411915779
• UDI-Public: 10607411915779
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 16SOFT-7-50
• Device Catalogue Number: 16SOFT-7-50
• Device Lot Number: (10)220223J
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown