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

Model Number M04

Device Problems Leak/Splash (1354); Defective Component (2292)

Patient Problems Pain (1994); Burn, Thermal (2530); Chemical Exposure (2570)

Event Date 02/09/2019

Event Type  Injury  

Event Description

Over the weekend, our son was hurt badly in his sleep with his malem alarm.For no reason at all, the alarm burnt him on his neck in the middle of the night when he was asleep.The incident occurred at 11:30 pm when we heard him crying out in pain.The alarm was set on him at 9:15 pm.When i reached his room, he had wet his bed.The malem alarm somehow detected urine, but did not wake him up by beeping or vibrating.The alarm was non-responsive when i reached.On observation, the batteries had leaked from the underside and some of it spread on his neck and clothes.Clearly a device defect.The alarm has burnt his neck and he is now recovering from the scare and trauma.The doctor¿s office has told us to report the incident to the fda and we have left the alarm with them.The alarm was purchased for treatment of nocturnal enuresis and has turned out to be a scare.

• Brand Name: MALEM BED WETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8336594
• MDR Text Key: 136507461
• Report Number: MW5083989
• 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: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M04
• Device Lot Number: BLUE COLOR
• Was Device Available for Evaluation?: No
• 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