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

Model Number ULTIMATE BEDWETTING ALARM

Device Problems Device Emits Odor (1425); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 08/31/2019

Event Type  Injury  

Event Description

Late last night, my daughter was injured while she was sleeping.The injury was a burn mark on her chest from a defect in her bedwetting alarm.The alarm was new and it was the first night it was used.Alarm is powered by aaa batteries.Not sure how or what caused this problem, but the alarm has overheated and injured my daughter.She is shaken up.I used (b)(6) on her burn to calm it down.I removed batteries from the alarm.Now when i reinsert batteries, it gets hot and smells bad.I removed the batteries and can't operate again.Fda safety report id# (b)(4).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8965253
• MDR Text Key: 157731295
• Report Number: MW5089568
• 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: 08/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE BEDWETTING ALARM
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR