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

Model Number ULTIMATE BLUE ALARM

Device Problem Defective Component (2292)

Patient Problems Erythema (1840); Swelling (2091)

Event Date 08/22/2019

Event Type  malfunction  

Event Description

After using the malem alarm for about 4 nights, my son has developed red blisters (small ones) on his neck and chest.This is where the alarm is touching his skin.It was not there before he started using the alarm and came only after continued use.I discontinued using the alarm and the blisters are gone.I tried again and in 2 nights, he got blisters again, this time on his left shoulder (first it was right shoulder).This has definitely got to be the malem alarm that is making him break out on his skin.I don't understand why it's happening, but it's scary.Fda safety report id# (b)(4).

• Brand Name: ALARM FOR BEDWETTING
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8949687
• MDR Text Key: 156322656
• Report Number: MW5089463
• 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: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE BLUE ALARM
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR