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

Model Number M042

Device Problem Overheating of Device (1437)

Patient Problem Burning Sensation (2146)

Event Date 05/21/2019

Event Type  Injury  

Event Description

My son was sleeping in his room with the malem bedwetting alarm.He came over 15 minutes later with his shirt removed and said that the alarm was hot and burning him so he removed his shirt as he was unable to take off the alarm.I went to his room and the alarm was very hot.I immediately removed the batteries and that cooled it down.I know the alarm did not fall or get damaged.It is defective.When i replaced batteries, the alarm starts getting hot again.Its something in the alarm that is making this hot.Not sure, but it¿s a short circuit of some kind.Fda safety report id # (b)(4).

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8654954
• MDR Text Key: 146706351
• Report Number: MW5086990
• Device Sequence Number: 0
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M042
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR