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

Model Number M05RB

Device Problems Overheating of Device (1437); Noise, Audible (3273)

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

Event Date 10/08/2018

Event Type  Injury  

Event Description

We are very disappointed with the quality of the malem bedwetting alarm which we recently purchased.The alarm worked fine the first night, but last night, it was behaving very erratic.When my daughter was inserting the sensor inside the alarm, it was making a rattle sound and starting to get hot.At first, we were not sure why the alarm was rattling, so we took out batteries and replaced them.Same thing happened.After 30 minutes the rattling became louder but the alarm was very hot.Dangerously hot for my daughter.There is something seriously wrong with the device that is causing it to rattle and overheat.Good thing she wasn't asleep or wearing it when sleeping or it could have been extremely dangerous as this is placed near her neck.

• Brand Name: MALEM ULTIMATE RECORDABLE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS - MALEM
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 7960237
• MDR Text Key: 123679610
• Report Number: MW5080510
• 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: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M05RB
• Device Catalogue Number: BLUE
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/11/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR
• Patient Weight: 21