FDA Adverse Event
Summary report: N
O2 TUBING
MDR report key: 7475134
·
Received April 30, 2018
Report
- Report Number
- MW5076904
- Date Received
- April 30, 2018
- Date of Event
- April 1, 2018
- Report Date
- April 26, 2018
- Manufacturer
- MEDLINE
- Product Code
- BZB
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
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."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 316883 | O2 TUBING | O2 TUBING | BZB | MEDLINE | 49115070001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Other |