MAUDE Adverse Event Report: UNKNOWN 24 URINE CONTAINER

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.

• Brand Name: 24 URINE CONTAINER
• Type of Device: URINE CONTAINER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 5938918
• MDR Text Key: 54408681
• Report Number: MW5064607
• Device Sequence Number: 0
• Product Code: FMH
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 09/05/2016
• Type of Device Usage: N
• Patient Sequence Number: 0
• Treatment: ALLERGA; BENADRYL; PREDNISONE; TYLENOL; ZANTAC
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Weight: 47