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

Device Problems Overheating of Device (1437); Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2019

Event Type  malfunction  

Event Description

The malem alarm is non-responsive and hot within 30 minutes of use.The button is not working and back is warm.The back is in contact with skin which makes it not safe to use on a sleeping child.If the alarm detects urine (did a water test), there is no way to turn it off, as button doesn't work.Heat will cause skin burn.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8416814
• MDR Text Key: 138763078
• Report Number: MW5084880
• 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: Unknown
• Type of Report: Initial
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4 YR