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

Model Number M SERIES

Device Problems Device Emits Odor (1425); Overheating of Device (1437); Vibration (1674)

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

Event Date 05/17/2019

Event Type  malfunction  

Event Description

New alarm is constantly vibrating when the sensor is inserted into the alarm.That results in the alarm itself heating up and the temperature at the back of the alarm starts to rise.Gradually, the alarm gets hotter and hotter and 30 mins later, it is so hot that you can't even hold it in your hand.I had to remove batteries to cool it down.Also, it smells bad like something inside the alarm is burning when it's hot.The back side of this device is too hot and the plastic has deformed from excess heat.It was purchased for my (b)(6) son who won't be using it for safety reasons.Fda safety report id# (b)(4).

• Brand Name: ULTIMATE ALARM FOR BEDWETTING
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8636645
• MDR Text Key: 146228641
• Report Number: MW5086862
• 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: 05/20/2019

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: Other
• Device Model Number: M SERIES
• Device Catalogue Number: 042
• Device Lot Number: BLUE COLOR
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/22/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Weight: 24