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

Model Number M4

Device Problems Burst Container or Vessel (1074); Overheating of Device (1437)

Patient Problems Erythema (1840); Swelling (2091); Injury (2348)

Event Date 02/20/2019

Event Type  Injury  

Event Description

The alarm was used exactly as the user manual and video demonstrated.However, the adverse reaction was still there and caused injuries to our child.My son is only (b)(6) and he is unable to install and remove the alarm on his own.He sleeps in his own room.When the alarm was placed i put him to sleep and there was nothing abnormal.I did not hear the alarm and just went in to check my son and he was moving in bed.I did not realize that the alarm was getting hot just from normal use.I went ahead and checked the connections and it's when i felt the hot alarm on my hand.I touched it further and it was really hot.My son was wearing a sweater and that saved him, but not for too long.After i removed the alarm, i saw a big red patch on his neck.The alarm stopped getting hot after some time because the heat caused the batteries to explode inside the alarm.I stopped using the alarm and gave him a warm rinse.Unfortunately he had some red blisters the following days and we took him to the doctor for treatment.The doctor advised to discontinue using the alarm and to report the incident.

• Brand Name: MALEM BED WETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8374806
• MDR Text Key: 137295400
• Report Number: MW5084443
• 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: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M4
• Device Catalogue Number: M4
• Device Lot Number: M4
• 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: 3 YR