MAUDE Adverse Event Report: MALEM MEDICAL LTD ULTIMATE ALARM; ALARM, CONDITIONED REPSONSE ENURESIS

Device Problem Unintended Electrical Shock (4018)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 06/29/2019

Event Type  malfunction  

Event Description

Today is the first night we are using the (b)(6) bedwetting alarm.I tested it by placing the sensor in my hands and putting water.I am getting a shock.I can feel a mild shock in my hands when the alarm is buzzing.I removed the sensor, changed batteries and retired.It constantly gives me shocks.I obviously cant use the alarm id it gives shocks.Its defective and scary to use.Fda safety report id # (b)(4).

• Brand Name: ULTIMATE ALARM
• Type of Device: ALARM, CONDITIONED REPSONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8760254
• MDR Text Key: 150385077
• Report Number: MW5087858
• 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: 06/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/02/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8 YR