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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN 24 URINE CONTAINER

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UNKNOWN 24 URINE CONTAINER Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Chest Pain (1776); Itching Sensation (1943); Burning Sensation (2146); Reaction (2414)
Event Date 08/26/2016
Event Type  Injury  
Event Description
Allergic reaction to sodium carbonate.Collecting a 24 urine sample with preservative of sodium carbonate.First started with itchy face, then burning of face and throat, itchy ears, itchy scalp, mid chest pain, feeling of swollen lips, all of which is still continuing after more than a week.I believe i have been allergic to other products but not aware that the problem was including frozen shrimp.Ramon noodles, detergents.Yet this was the worst reaction.Quest diagnostics.
 
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Brand Name
24 URINE CONTAINER
Type of Device
URINE CONTAINER
Manufacturer (Section D)
UNKNOWN
MDR Report Key5938918
MDR Text Key54408681
Report NumberMW5064607
Device Sequence Number0
Product Code FMH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/05/2016
Type of Device Usage N
Patient Sequence Number0
Treatment
ALLERGA; BENADRYL; PREDNISONE; TYLENOL; ZANTAC
Patient Outcome(s) Other;
Patient Age39 YR
Patient Weight47
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