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

Model Number M05

Device Problems Break (1069); Leak/Splash (1354); Melted (1385); Device Emits Odor (1425); Overheating of Device (1437)

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

Event Date 04/02/2019

Event Type  Injury  

Event Description

Son was sleeping with bedwetting alarm at night and complained of burning smell from device.On checking, i noticed that the alarm was warm and promptly removed it.It took about 20 minutes and the alarm batteries exploded inside the device and leaked out of the device.The process generates so much heat that it deformed the back of the alarm.Fda safety report id #: (b)(4).

• Brand Name: MALEM BED WETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8501049
• MDR Text Key: 141578091
• Report Number: MW5085753
• 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: 04/05/2019

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: Lay User/Patient
• Device Model Number: M05
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR