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

Model Number M04

Device Problem Overheating of Device (1437)

Patient Problems Erythema (1840); Burn, Thermal (2530)

Event Date 07/05/2018

Event Type  Injury  

Event Description

My daughter was burnt in her neck by the malem bedwetting alarm which she used over the weekend.When we reached out to help my daughter, the alarm was extremely hot and it had burnt her in the neck.There were small red patches on her neck from the heat and she had to be quickly treated for burns.I am disappointed that this happened within an hour of powering on the device.If i had not reached on time, it would have been fetal in my opinion.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 7681118
• MDR Text Key: 113795740
• Report Number: MW5078317
• 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: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR