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

Model Number M05

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 03/19/2019

Event Type  Injury  

Event Description

I am a pharmacist and i purchased a malem alarm for my son who suffers from bedwetting.The alarm has malfunctioned the very first night it was used and has injured my son at the point where the alarm touches skin.He has burn marks from an overheating alarm.There was no damage to the alarm at night when we used it.It was new.All we did was insert batteries and power up the alarm.The device has injured him and the cause of it that it overheated in under 1 hour of use.

• Brand Name: MALEM
• Type of Device: ALARM CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8444314
• MDR Text Key: 139706315
• Report Number: MW5085094
• 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: 03/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M05
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR