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

Model Number M05 SELECTABLE ALARM

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 12/18/2018

Event Type  Injury  

Event Description

We have twin bedwetters and the dr recommend using an alarm and medication combination to overcome bedwetting.Purchased two malem ultimate bedwetting alarms online and neither works correctly.They have a problem when the monitor is turned on and the cable is inserted, the system gets hot.Both sons were wearing it and one complained of burning / stinging.The alarm heat burnt him.Surprised that both alarms have what appears to be a manufacturing defect that is making it so hot under normal use.Discontinued use and reported to pediatrician who said this brand has had other issues in the past.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8208437
• MDR Text Key: 132102799
• Report Number: MW5082720
• 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: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M05 SELECTABLE ALARM
• 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: 7 YR