MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-30 for O2 TUBING RA11SWY manufactured by Medline.
[107195559]
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. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076904 |
| MDR Report Key | 7475134 |
| Date Received | 2018-04-30 |
| Date of Report | 2018-04-26 |
| Date of Event | 2018-04-01 |
| Date Added to Maude | 2018-05-01 |
| 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 |
| Brand Name | O2 TUBING |
| Generic Name | O2 TUBING |
| Product Code | BZB |
| Date Received | 2018-04-30 |
| Catalog Number | RA11SWY |
| Lot Number | 49115070001 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-30 |