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

Model Number M043

Device Problems Gel Leak (1267); Overheating of Device (1437); Smoking (1585)

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

Event Date 06/24/2019

Event Type  Injury  

Event Description

Set up the malem bedwetting alarm exactly as the user manual said.Placed alarm on my daughter's neck and the sensor outside her panties.She went to sleep.I heard the alarm went off at 2:30am and went to wake her up.I woke her and removed the moisture sensor and pressed the malem turn off the button.The alarm went off, however it really did not.I thought it wasn't making sounds and vibrating, it was getting hot.My daughter said she was feeling heat from the alarm and smelt of something burning.I removed the alarm and noticed that it was warm.I placed it on the bed and changed my daughter.When we returned, the alarm had smoke coming from it and 5 mins later, it stopped getting hot.I was unable to remove batteries as i was scared it might injure me.When it cooled, the back was slippery as batteries leaked out.Alarm is unusable and just unit for normal operation.Fortunately no one was injured.Fda safety report id# (b)(4).

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8758143
• MDR Text Key: 150121506
• Report Number: MW5087797
• 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: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M043
• Device Catalogue Number: ULTIMATE BEDWETTING ALARM
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8 YR