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

Model Number BEDWETTING ALARM

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock (2072)

Event Date 09/12/2019

Event Type  Injury  

Event Description

My daughter has been diagnosed with autism and she wets the bed at night.Pediatrician prescribed a bedwetting alarm.She has used it for 3 nights and has complained that she gets a shock when the alarm detects urine.She has said that the shock was severe in intensity to ake her up.I didn't believe at first, but after the third night, she refused to wear it and i noticed that the batteries were dead.I put in new batteries and put the sensor under a faucet.When i touched the sensor, i got a shock.I can't believe that i forced my daughter to sleep with this alarm when she was getting shocks on her skin.I reported this to the pediatrician and tried to reach out to malem several times.No response from the company.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: 9086683
• MDR Text Key: 159382800
• Report Number: MW5089880
• 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: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BEDWETTING ALARM
• 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