MAUDE Adverse Event Report: SALTER LABS ADULT CANNULA

Model Number 1600-7

Device Problem Nonstandard Device (1420)

Patient Problems Burn(s) (1757); Pulmonary Emphysema (1832); Scarring (2061)

Event Date 05/06/2015

Event Type  Injury  

Event Description

I have pulmonary hypertension and emphysema.I require oxygen as a result.I have to wear a cannula, after about a year on oxygen without any problems my provider (b)(4) sent me some cannulas made by a company called salter labs in (b)(4).The product is made in (b)(4) and what it did was it burned and caused blistering scabbing and scaling of my neck and around my ears and nose and my neck suffered the worst damage and i now have vitiligo which probably will not go away.My doctor recommended that i put cortizone 10 on it which did stop the scaling and itching and it did heal it but i am now scarred for life with these large white blotches all over my neck.I am native american and as such my skin is dark and now i have these white spots that stand out in contrast to my skin.I tried them for several weeks.I even asked my provider (b)(4) for some type of cover that i could put over them but it was not long enough, they would just shut 4 inch pieces.The item is a nasal cannula and its product number is ref in a box followed by the numbers and letters 1600 tlc - 7.The lot or batch number is (10).Followed by 0 72015 the upc code is 607-4011 10154 manufactured by salter labs (b)(4), it does have a pht warning and plainly states not for sale in (b)(4).

• Brand Name: ADULT CANNULA
• Type of Device: ADULT CANNULA
• Manufacturer (Section D): SALTER LABS
• MDR Report Key: 5471129
• MDR Text Key: 39444503
• Report Number: MW5060636
• Device Sequence Number: 1
• Product Code: NHJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/06/2020
• Device Model Number: 1600-7
• Device Lot Number: (10)072015
• Other Device ID Number: 0607411101540
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 85