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

Model Number M042

Device Problems Defective Alarm (1014); Inappropriate/Inadequate Shock/Stimulation (1574)

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

Event Date 07/03/2019

Event Type  Injury  

Event Description

My son has been using malem alarm for 2 night and he was wet 2-3 times a night during those 2 days.Each time, the malem alarm went off, my son complained that he was getting shocks.I didn¿t believe him the first night but the second night, when he complained, i tested the alarm and it gave me a shock on my hands when it was wet.The alarm is defective and gives shock on genitals.As a nurse, i am concerned about the safety of a device which shocks children in their sleep.Fda safety report id # (b)(4).

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL; GB
• MDR Report Key: 8772437
• MDR Text Key: 150668755
• Report Number: MW5087946
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M042
• Device Catalogue Number: ULTIMATE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 7 YR