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

Model Number M05S

Device Problem Temperature Problem (3022)

Patient Problems Burn(s) (1757); Pain (1994)

Event Date 03/17/2019

Event Type  Injury  

Event Description

We have two children and both use a bedwetting alarm.One of our son's alarm has developed a defect and it would get very hot within a few mins of use.I overlooked it and thought that this may be normal operation and placed on my son.I regret that.He was in pain and crying when i checked on him.He had removed the alarm from his body and i noticed a big red scar on his neck area where the alarm connects.The alarm got so hot under usual operation and somehow burnt my son's neck.The other alarm was operating fine, but was warm too.I treated my son at home and he will recover.It is important to note the device failure though.

• Brand Name: MALEM ULTIMATE SELECTABLE BEDWETTING ALARM
• Type of Device: ALARM CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8443944
• MDR Text Key: 139601550
• Report Number: MW5085070
• 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: 03/19/2019

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: M05S
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR