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

Model Number M042-BLUE

Device Problems Break (1069); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 05/13/2019

Event Type  Injury  

Event Description

Daughter was sleeping with bedwetting device and she felt strong heat burning her neck.She came over and reported to me.I checked and realized that it was the bedwetting alarm.It was overheated and hot.I removed it and used different batteries but same thing happened.We used nighthawk alarm before this with no problem.It broke and we bought this alarm.Alarm is getting hot and daughter is frightened to use it.Will not use it anymore.It is risky and can cause skin burning on the neck, it is so hot.Fda safety report id# (b)(4).

• Brand Name: ALARM FOR BEDWETTING
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 8624590
• MDR Text Key: 145683884
• Report Number: MW5086756
• 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: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M042-BLUE
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR