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

Model Number M04

Device Problems Leak/Splash (1354); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 06/26/2019

Event Type  malfunction  

Event Description

This is quite possibly the worst purchase i ever made.It may also qualify as the worst product available for the treatment for bedwetting.My son used it for just one night and he was burnt by the hot alarm.I can't understand how or why this alarm got so hot in the first place.The heat caused the batteries to leak out and there is slippery sticky material all over the product.This makes it not safe and highly unreliable.Plus it gets so hot! i was fortunate my son was able to remove the alarm promptly or he would get burnt.The temperature on this device easily touches 150f.I noticed it and left it in the bathroom sink for fear of it exploding and causing injuries.It is an awful product.Fda safety report id # (b)(4).

• Brand Name: MALEM MEDICAL
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8760228
• MDR Text Key: 150409773
• Report Number: MW5087856
• 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: 06/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8 YR