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

Model Number M05

Device Problems Melted (1385); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Event Description

The bedwetting alarm prescribed by the dr has had an adverse reaction and injured my daughter.She was sleeping at night wearing the alarm and 4 mins into her sleep, she cried loudly and complained of burns.I thought it is just not possible since this is a battery operated product, but i was wrong.She had indeed been burnt at the point where the alarm touched her skin.She was holding the t-shirt away to prevent more harm.I also noticed that the alarm was so hot that the back door had deformed from heat.Overall not safe and pretty scared that this happened.I was able to treat her on time at home, but found it useful to report.

• Brand Name: ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8101934
• MDR Text Key: 128453373
• Report Number: MW5081594
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M05
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/23/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 7 YR
• Patient Weight: 35