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

Model Number ULTIMATE BEDWETTING ALARM

Device Problem Overheating of Device (1437)

Patient Problem Burning Sensation (2146)

Event Date 02/22/2019

Event Type  malfunction  

Event Description

The malem alarm is hot and stinging my son's skin near his shoulder.We can't use this alarm.Only way to cool it is to remove batteries.It was installed and within minutes son complained of stinging from heat.Not good and not safe.

• Brand Name: MALEM
• Type of Device: ALARM CONDITONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8371705
• MDR Text Key: 137368249
• Report Number: MW5084382
• 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: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE BEDWETTING ALARM
• Device Catalogue Number: M04
• 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): Other
• Patient Age: 5 YR