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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE O2 TUBING

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MEDLINE O2 TUBING Back to Search Results
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.".
 
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Brand Name
O2 TUBING
Type of Device
O2 TUBING
Manufacturer (Section D)
MEDLINE
MDR Report Key7475134
MDR Text Key107195559
Report NumberMW5076904
Device Sequence Number1
Product Code BZB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 NumberRA11SWY
Device Lot Number49115070001
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/30/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age77 YR
Patient Weight49
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