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

Model Number M

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Shock (2072); Tingling (2171)

Event Date 05/19/2019

Event Type  malfunction  

Event Description

Alarm is giving small shocks when the sensor is getting wet.I can feel a tingling effect on my fingers when i hold a wet sensor.Cannot use this on a child who is wet.It can and will shock the genitals.He will be asleep.I changed batteries and this keeps happening.Shock treatment is not what the device is supposed to do.Unsafe.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: 8631888
• MDR Text Key: 145934602
• Report Number: MW5086806
• 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: 05/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M
• Device Catalogue Number: 042
• Device Lot Number: BLUE
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Weight: 15