MAUDE Adverse Event Report: MALEM MEDICAL UK MALEM ULTIMATE SELECTABLE BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS

Device Problems Fluid/Blood Leak (1250); Temperature Problem (3022)

Patient Problems Pain (1994); Injury (2348); Burn, Thermal (2530)

Event Date 08/03/2018

Event Type  Injury  

Event Description

In what appears to be a device malfunction, my son was hurt while sleeping just by using the bed wetting alarm.The bedwetting alarm was purchased a week ago and it seemed to work fine for 3 days, then on friday nigh, he was asleep in bed and screamed in pain as the alarm burnt him.When i went to help him, i noticed that the alarm was pulled out by him and taken on the ground.The alarm had batteries leaking out of the back and it was extremely hot.So hot that it was not possible to hold it in the hand.My son has skin burns from this alarm.It has been returned to (b)(6)where it was purchased.

• Brand Name: MALEM ULTIMATE SELECTABLE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL UK; UK
• MDR Report Key: 7769647
• MDR Text Key: 116711382
• Report Number: MW5079014
• 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: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2018
• 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: 19