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

Catalog Number M042

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Erythema (1840); Rash (2033); Swelling (2091); Electric Shock (2554)

Event Date 06/27/2019

Event Type  malfunction  

Event Description

My son has been using the malem bedwetting alarm for 3 nights and has been complaining of skin rash in his genitals.He has redness and swelling on his private parts.I was unsure of the cause and applied lotion on him.At night, i tested the alarm on my hand and i got a shock.All i did was test the alarm with salt water on my hands and i got a mild shock.I was scared.It is clearly why my son is getting redness, its from shocks that the alarm gives when he is getting wet.I have reached out to the company several times, but no reply to email or phone calls.Fda safety report id # (b)(4).

• Brand Name: MALEM ULTIMATE BEDWETTIGN ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8760216
• MDR Text Key: 150385493
• Report Number: MW5087855
• 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: 06/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: M042
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR