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

Model Number M04SB - ROYAL BLUE

Device Problem Temperature Problem (3022)

Patient Problems Bruise/Contusion (1754); Burn, Thermal (2530)

Event Date 09/26/2018

Event Type  Injury  

Event Description

My son is a chronic bedwetter and he is already (b)(6) now.At the advice of friends, we decided to try out a bedwetting alarm for him.I found an advertisement for bedwetting alarm on (b)(6) and purchased a malem bedwetting alarm - single tone for my son.We had hoped that the alarm would stop his bedwetting habit, but the problem was far worse.The brand new alarm was placed on my son last night as he kept and an hour later, he was frightened and he screamed out loudly.When we checked on him, he said that the alarm burnt him.It was very hot and easily burnt his skin on contact.It was late at night, so i gave him a burn ointment on his skin.But now, a day later, it's bruised and he has blisters on his skin.I regret having purchased this alarm and we are very disappointed.Had expected results, but the alarm instead burnt his skin.He is terrified to use another such alarm.I am certain that so much heat it not normal for a device that a child uses.

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 7922176
• MDR Text Key: 122303487
• Report Number: MW5080202
• 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: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04SB - ROYAL BLUE
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR
• Patient Weight: 26