MAUDE Adverse Event Report: URIFOON BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS

Device Problem Overheating of Device (1437)

Patient Problems Erythema (1840); Swelling (2091)

Event Date 01/28/2019

Event Type  malfunction  

Event Description

After no success with the urifoon bedwetting alarm, we tried using the malem alarm for my daughter.The urifoon gave us several false alarms.The malem alarm was a replacement.It was not good.My daughter slept through the night wetting her bed but the alarm did not go off.In the morning, i noticed that the alarm was hot and my daughter has blisters on her neck and red patches.The alarm comes in contact with skin and this is where the blisters happened.Although the alarm works, it is not safe to use.

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): URIFOON
• MDR Report Key: 8305523
• MDR Text Key: 135554273
• Report Number: MW5083680
• Device Sequence Number: 2
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/31/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 YR