ADULT CANNULA 1600-7

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-26 for ADULT CANNULA 1600-7 manufactured by Salter Labs.

Event Text Entries

[39444503] 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).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5060636
• MDR Report Key: 5471129
• Date Received: 2016-02-26
• Date of Report: 2016-02-26
• Date of Event: 2015-05-06
• Date Added to Maude: 2016-03-01
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: ADULT CANNULA
• Generic Name: ADULT CANNULA
• Product Code: NHJ
• Date Received: 2016-02-26
• Model Number: 1600-7
• Lot Number: (10)072015
• ID Number: 0607411101540
• Operator: LAY USER/PATIENT
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SALTER LABS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2016-02-26