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

Model Number M04S

Device Problem Overheating of Device (1437)

Patient Problem Pain (1994)

Event Date 02/04/2018

Event Type  malfunction  

Event Description

The enuresis alarm that my son prescribed got so hot at night that my son screamed in pain.This alarm has some problem.I was using another brand which was not very effective, so the dr told us to switch to this alarm.The problem is that it gets very hot and the heat hurt my son.Stopped using it.

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7266508
• MDR Text Key: 99998905
• Report Number: MW5075196
• 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: 02/09/2018

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: Lay User/Patient
• Device Model Number: M04S
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 3 YR