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

Model Number M042

Device Problem Temperature Problem (3022)

Patient Problem Rash (2033)

Event Date 06/04/2019

Event Type  malfunction  

Event Description

My son has been using malem alarm for 1 week and he's developed skin rash from plastic touching his body.I have cleaned the alarm with dry napkin and used it correctly, but he still has skin rash.The rash is small red patches which can be the result of heat from the alarm.The alarm is warm when he's wearing it.I make sure he wears a thin shirt every time he uses this alarm.But after this skin irritation getting worse, i have discontinued using the device.Worried that something in the device is causing skin rash.Also, the alarm stinks of burning plastic when used.Fda safety report id# (b)(4).

• Brand Name: BEDWETTING ALARM BY MALEM
• Type of Device: ALARM CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8691740
• MDR Text Key: 147886207
• Report Number: MW5087272
• 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: 06/09/2019

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: Lay User/Patient
• Device Model Number: M042
• Device Catalogue Number: ULTIMATE ALARM
• Device Lot Number: BLUE COLOR
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR