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

Model Number M04B

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 12/26/2018

Event Type  Injury  

Event Description

Last night, we had a major scare when son was burnt with his bedwetting alarm.Operating as per the instructions and barely used for an hour when son complained of burns from hot object on his skin.He is too young to be able to remove it, so he kept crying with the alarm connected to his body and we heard it at night and quickly went to help him.The alarm burnt his skin where it touched and he got big red blisters.After removing the alarm from him, we forgot to remove batteries and noticed that an hour later, the alarm battery holder bent from heat and batteries leaked out or exploded within the alarm.Overall a major scare for us at 11pm.This alarm has a problem.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8208446
• MDR Text Key: 132127319
• Report Number: MW5082721
• 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: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04B
• Device Catalogue Number: BLUE COLOR
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR