MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM BEDWETTING ALARM FOR TREATMENT OF BEDWETTING ; ALARM, CONDITION RESPONSE ENURESIS

Model Number MALEM

Device Problem Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/11/2019

Event Type  Injury  

Event Description

My daughter is a bedwetter and we purchased the malem ultimate alarm to help her stop her bedwetting.The new alarm is not working properly and instead it is operating unsafe.The alarm uses two batteries to operate.However when i am placing batteries, the alarm is getting very hot.I thought that this may be normal at first, but the heat is not reducing and only increasing.The first time that i placed batteries, everything seemed fine and then it started getting hot as it sat in my hand and kept getting hot, i promptly removed batteries and tried another pair, but this is getting hot with every battery.It's a new alarm and it should not do this.I don't know how hot it will eventually get, but within 15 mins, it's hot enough not to be held in the hands.Will have to return it for safety purposes.Fda safety report id# (b)(4).

• Brand Name: MALEM BEDWETTING ALARM FOR TREATMENT OF BEDWETTING
• Type of Device: ALARM, CONDITION RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8612211
• MDR Text Key: 145233603
• Report Number: MW5086643
• 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: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MALEM
• Device Catalogue Number: ULTIMATE VERSION
• Device Lot Number: M
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR