MAUDE Adverse Event Report: MALEM MEDICAL LTD BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number M04S

Device Problems Overheating of Device (1437); Product Quality Problem (1506)

Patient Problem No Code Available (3191)

Event Date 11/26/2018

Event Type  Injury  

Event Description

We have purchased a new malem bedwetting alarm at the recommendation of our son's pediatrician.This alarm was purchased with high hopes, so he would stop night time wetting.However the alarm is not working normally.Today is the first night i am using it and it is turning very hot.This is clearly not normal.The alarm backside warms up within mins of sensor insertion and keeps warming up till it is dangerously hot.There is absolutely no way that this can be worn by a young child (my son is(b)(6)) without causing severe skin burns.I have looked carefully at videos, user manuals and everything else, but this is clearly a mfg defect or a design problem whatever be the case, this is not safe for my son.

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8110725
• MDR Text Key: 128738945
• Report Number: MW5081651
• Device Sequence Number: 1
• 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: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04S
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Weight: 16