MAUDE Adverse Event Report: MEDLINE O2 TUBING

Catalog Number RA11SWY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Irritation (1941); Itching Sensation (1943)

Event Date 04/01/2018

Event Type  No Answer Provided  

Event Description

I have itching and irritated red skin and feel sure it is the new o2 soft tubing given me by the tech who checks my concentration and the label on the soft light green hudson rci tubing said non deph and the clear soft tubing contains deph.I read a lot online and wondering if i can be allergic to it.I am allergic to sulfa drugs and codeine.I have had (b)(6) 4 yrs ago and then psoriasis.This is a red irritated area where the tubing touches behind my ears, my face and neck.Can i be allergic to this new softer tubing.Dates of use: (b)(6) 2018.Diagnosis or reason for use: night concentrator for copd."is the product compounded: yes; is the product over-the-counter: no.".

• Brand Name: O2 TUBING
• Type of Device: O2 TUBING
• Manufacturer (Section D): MEDLINE
• MDR Report Key: 7475134
• MDR Text Key: 107195559
• Report Number: MW5076904
• Device Sequence Number: 1
• Product Code: BZB
• Combination Product (y/n): N
• 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: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RA11SWY
• Device Lot Number: 49115070001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Weight: 49