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

Model Number M04

Device Problems Electrical Shorting (2926); Temperature Problem (3022)

Patient Problem No Information (3190)

Event Date 03/12/2019

Event Type  Injury  

Event Description

Our malem alarm is malfunctioning.With batteries and sensor connected, the alarm is getting warm.It appears that something is moving inside the alarm which is generating heat.Looks like the thing that vibrates is stuck and shorting out thereby producing heat for the alarm.When the alarm is on and sensor is placed inside the bottom, the alarm temperature starts to rise and gets too hot to hold.This is not safe to operate when my daughter is sleeping as it can easily burn her.I have contacted the mfr three times, but not received any response.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8448189
• MDR Text Key: 139751708
• Report Number: MW5085107
• 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: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M04
• 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