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

Model Number M04S

Device Problems Leak/Splash (1354); Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Date 11/04/2018

Event Type  malfunction  

Event Description

I am reporting a failure and malfunction with a night time bedwetting alarm.The malem bedwetting alarm has malfunctioned.It has become very hot and the batteries leaked making it unusable.The alarm was sitting on the table when this happened.Fortunately, i did not make my son wear it or he probably would be injured.I am disappointed that the alarm lasted 30 mins.Risky to use.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED, RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8054931
• MDR Text Key: 126964432
• Report Number: MW5081163
• 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
• Type of Report: Initial
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M04S
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 7 YR