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

Model Number M04

Device Problem Overheating of Device (1437)

Patient Problems Rash (2033); Burn, Thermal (2530)

Event Date 09/13/2018

Event Type  Injury  

Event Description

We were using an enuresis alarm without much success and migrated to the malem alarm with very bad results.The malem alarm was purchased new from (b)(6) website and it arrived within a few days.The alarm was a serious defect.As soon as i placed batteries and connected to the sensor, the alarm got hot and within an hour, the backside burnt my daughter's neck.She was sleeping and did not realize.By the time she did, the alarm had burnt her neck and caused skin rash.Very strange how a small device like this could burn a child's neck.So much heat was produced by the system.Very dangerous.

• Brand Name: MALEM MEDICAL ENURESIS AND BEDWETTING ALARM
• Type of Device: ALARM CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 7889069
• MDR Text Key: 120838434
• Report Number: MW5079870
• 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: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem 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: 09/18/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 3 YR