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

Model Number M05

Device Problem Overheating of Device (1437)

Patient Problem Rash (2033)

Event Date 12/20/2018

Event Type  malfunction  

Event Description

After about a week of using the alarm, my son has got a serious case of skin rash on his neck.Initially, it seemed strange, as it was only plastic that touched his neck, but then we realized that the alarm is heating up every time he is using it.This is causing skin irritation.I was using another brand unsuccessfully, but this never happened the alarm is warm like a cell phone that is charging and that heat caused skin irritation.My son is only(b)(6) and this is not good for him.The irritation is in the form of small blisters on his neck and small red patches.The doctor advised i immediately discontinue use and report the incident to the fda.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8202997
• MDR Text Key: 131900320
• Report Number: MW5082664
• 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: 12/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M05
• 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