MAUDE Adverse Event Report: SALTER LABS NASAL CANNULA

Model Number	1600
Health Effect - Clinical Codes	Pain (1994); Skin Irritation (2076); Burning Sensation (2146)
Date of Event	01/01/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
I have been on oxygen over twenty years (over time, the supplier company changed).About five years ago i noticed a burning pain behind my right ear.It came and went but was worse and larger each time.I started seeing a dermatology dr repeated biopsy were done, then i had to have the mdu micrographic surgery, where as the entire back of my ear was removed to the hair line top to chin bone.I questioned the dr as to the "cannula" hose causing the problem, he made no comment yes or no.However, i know that this is the cause because the ear that the surgery was done on, now has a new one, where the hose now lays.Just off the scar and my left ear same location, same problem (no surgery yet) as well as the nostrils of my nose color change, weeping, burning, goes away, comes back bigger.On (b)(6) 2019, again saw dr (b)(6), who again started.Dry skin yet it is the exact one as before forming where the cannula hose touches the chin.My left ear is real sore, burning, weeping, and getting bigger.But, i am being told that no one has ever had skin cancer, from an oxygen hose? the oxygen company is (b)(6).I never had this unit until i was assigned this company.Suicidal, chronic pain.
Event or Problem Description
Add'l info received for report mw5088933 from reporter on 08/14/2019.Pt states cancer is back again.Pt also stated she was told by the man that services her oxygen that other pts using the same device have reported dry sore areas behind their ears.

• Brand Name: NASAL CANNULA
• Common Device Name: NASAL CANNULA
• Manufacturer (Section D): SALTER LABS
• MDR Report Key: 8880414
• Report Number: MW5088933
• Device Sequence Number: 10826441
• Product Code: CAT
• UDI-Device Identifier: 00607411100246
• UDI-Public: 0607411100246
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 08/14/2019

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: No Information
• Device Model Number: 1600
• Device Lot Number: (10) 080811
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 08/14/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "CAINS"; ADVAIR PUFFS; ALLEGRA; AMMONIUM LACTATE; B VIT ; B12; CLONAZEPAM; CT DYE; FLEET PHOSPHO SODA; GLEERCE; IRON; LEXAPRO; LYRICA; MIDODRINE; OXYCODONE; PANTOPRAZOLE; PHENOBARBITAL ; PREDNISONE; PRO AIR HFA; RESTASIS; SOMA COMPOUND; SPIRIVA RESPIMAT PUFFS
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Weight: 45