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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SALTER LABSNASAL CANNULA TUBING-ADULTOXYGEN TUBING

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SALTER LABS NASAL CANNULA TUBING-ADULT OXYGEN TUBING   Back to Search Results
Event Date 06/06/2009
Event Type  Injury   Patient Outcome  Other
Event Description

Pt had reaction to oxygen tubing because allergy to corn starch and tubing contains corn starch per the pt allergies. There is not a warning on label of tubing to alert staff, pt to use caution with pts with corn allergies. Dose: 2 liters. Frequency: continuous. Route: nasal. Dates of use: continuous, 2009. Diagnosis: chronic hypoxia. Event abated after use stopped: yes.

 
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Brand NameNASAL CANNULA TUBING-ADULT
Type of DeviceOXYGEN TUBING
Manufacturer (Section F)
SALTER LABS
100 west sycamore rd
arvin CA
Manufacturer (Section D)
SALTER LABS
100 west sycamore rd
arvin CA
Device Event Key1557458
MDR Report Key1514236
Event Key1441225
Report NumberMW5013122
Device Sequence Number1
Product CodeCAT
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 10/19/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/19/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date01/01/2012
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?

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