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

Model Number M041

Device Problems Overheating of Device (1437); Defective Component (2292)

Patient Problem Burn, Thermal (2530)

Event Date 04/09/2019

Event Type  Injury  

Event Description

On the recommendation of my son's pediatrician, we used a malem bedwetting alarm for the very first time last week ((b)(6)).The device has a malfunction.It requires batteries and a sensor (to detect urine).The sensor was connected and batteries were inserted.The device should wake up my son when he urinated.Instead of waking up my son by alerts, the device got hot when he was sleeping.He did not realize how hot it was till it go too hot and burnt him.He sleeps with a thin t-shirt and the heat from the backside of the device was too much and burnt him.He was treated in the nearby er and we visited his pediatrician who recommended that we file this incident with the fda.We have left the alarm with the pediatrician who has said that this has happened with another pt recently.My son has burns on his neck.They appear to be rash and scars.A week later, they are still there and have not gone away.Fda safety report id# (b)(4).

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8541098
• MDR Text Key: 142917315
• Report Number: MW5086063
• 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: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M041
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3 YR