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

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885)

Patient Problems Pain (1994); Electric Shock (2554)

Event Date 09/27/2019

Event Type  Injury  

Event Description

My son used the malem alarm for one night, last night and he got a dangerous shock on his privates when he wet the bed.He was scared and shouting in pain.He was crying when i reached him.He said that he was asleep and when he wet, the alarm detected urine and gave him a shock.This is not supposed to be a shock treatment.When i checked the alarm, the batteries dried out.They had discharged completely.These are new batteries which came with the alarm.To retest, i put in fresh (b)(6) batteries and put some water on the sensor.I noticed that i got a big shock on my hand too.After 5 mins that battery discharged as well.This means that the alarm is giving massive shocks and discharging the batteries.Horrible and extremely dangerous.Fda safety report id# (b)(4).

• Brand Name: MALEM ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9145489
• MDR Text Key: 161045667
• Report Number: MW5090140
• 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: 09/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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: 4 YR