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

Model Number ROYAL BLUE MODEL

Device Problems Vibration (1674); Temperature Problem (3022)

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

Event Date 01/14/2019

Event Type  malfunction  

Event Description

My son has only used his bed wetting device for 3 nights and each night, it has caused problem for us.The first night, it started vibrating without any need and once that stopped, its temperature on the outside started to increase.The next night, the same thing happened and we discontinued using it.Finally, we changed the batteries and reused the device, but this time, the vibration didn¿t happen; it got uncontrollably hot.Could have injured my son.Not safe.Stopped using this device for safety reasons.

• Brand Name: MALEM BEDWETTING ALARM DEVICE
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8289742
• MDR Text Key: 135014537
• Report Number: MW5083481
• 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: 01/25/2019

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: ROYAL BLUE MODEL
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 YR
• Patient Weight: 14