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

Device Problems Display or Visual Feedback Problem (1184); Temperature Problem (3022)

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

Event Date 12/14/2018

Event Type  Injury  

Event Description

My daughter was sleeping as usual with her nighttime wetting alarm.She complained that it was hot and when i checked, it was indeed hot.I removed it and kept it on the side.After 15 mins, it was extremely hot.I could hear a vibration in the alarm portion.When the sensor is removed, the vibration stopped and it started to cool down, but with the sensor connected, it's hot.I worry that it would get hot to a point where it would just burn my daughter in her sleep.Discontinued use after 3 nights.Bad product.

• Brand Name: BEDWETTING ALARM FOR CHILDREN
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8180307
• MDR Text Key: 131050721
• Report Number: MW5082266
• 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: 12/15/2018

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR
• Patient Weight: 34