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

Model Number ULTIMATE ALARM

Device Problem Temperature Problem (3022)

Patient Problems Pain (1994); Skin Irritation (2076)

Event Date 03/09/2019

Event Type  Injury  

Event Description

Ever since we have started using the malem alarm for our daughter, she has been getting sores on her neck.We initially thought it was an allergic reaction to the plastic, but after 3 nights, we have concluded that the sores are from the alarm getting hot and irritating her skin.This is clearly happening because in the morning, when we removed the alarm, i noticed that it was very warm and this is likely the cause of skin reaction from heat as it is in contact with her body for 10 hours each night.When she wet the bed, it never once detected her urine, just kept on irritating skin.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8416754
• MDR Text Key: 138794969
• Report Number: MW5084876
• 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: 03/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE ALARM
• Device Catalogue Number: M04
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5 YR